Model 2002 Maestro Rechargeable NeuroregulatorRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00857334004262), received between Nov 5, 2015 and May 7, 2019 — classified as 8 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (18 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2019Failure to Charge; Failure to Charge

  THE PATIENT VISITED THE CLINIC ON (B)(6) 2019 COMPLAINING OF A FLASHING LIGHT ON THE MOBILE CHARGER WITH AN ERROR CODE 25 DISPLAYED. THE CLINIC REACHED OUT TO RESHAPE LIFESCIENCES FIELD CLINICAL SPECIALIST TO REPORT THE ISSUE AND THE FIELD CLINICAL SPECIALIST ASKED TO HAVE THE PATIENT BROUGHT BACK IN FOR FURTHER INVESTIGATION. ON (B)(6) 2019, THE PATIENT WAS SEEN BY THE CLINIC. THE DEVICE LEAD IMPEDANCE ON THE ANTERIOR TIP TO POSTERIOR TIP WAS 1583 OHMS. WITH AN IMPEDANCE ABOVE 1500 OHMS, THERAPY WILL NOT BE DELIVERED. THE CLINIC SUGGESTED THE PATIENT HAVE A COMPLETE REMOVAL OF THE DEVICE. THE REMOVAL OF THE DEVICE IS SCHEDULED FOR ON (B)(6) 2019.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 8586248 ↗
• MalfunctionOct 11, 2018Activation Problem; Activation Problem

  ON (B)(6) 2018, PATIENT 835-BAM AT SKYRIDGE EXPERIENCED A RED FLASHING LIGHT ON THE MC WHEN CONNECTING WITH THE RNR AT A POST-OP VISIT. THE RESHAPE FIELD SPECIALIST TRIED SEVERAL TIMES TO CLEAR THE FLASHING RED LIGHTS WHEN CONNECTED TO THE CP, HOWEVER, THE CP "LOCKED UP." THE FIELD SPECIALIST THEN HOOKED UP ANOTHER RNR (IMPLANT KIT) TO THE CP, THE RED LIGHT DISAPPEARED AND A GREEN FLASHING LIGHT APPEARED ON THE MC SIGNALING THE PATIENT WAS RECEIVING THERAPY. THE RNR LOGS WERE UNABLE TO UPLOAD DUE TO THE LOCK OUT ON THE CP, HOWEVER, DEBUG AND DATA FILES WERE SENT FOR INVESTIGATION. ON (B)(6) 2018, THE FIELD SPECIALIST MET WITH THE PATIENT TO ATTEMPT TO CONNECT THE DEVICE TO THE CP AGAIN TO CLEAR THE ALARMS. AFTER SEVERAL ATTEMPTS, THE CP WAS REMAINED LOCKED. THE FIELD SPECIALIST EXPRESSED TO THE IMPLANTING PHYSICIAN IF THEY ARE UNABLE TO RESOLVE THIS ISSUE, REVISION SURGERY MAY BE NECESSARY. ON (B)(6) 2018, THE IMPLANTING PHYSICIAN PERFORMED REVISION SURGERY, REMOVED THE RNR AND REPLACED WITH A NEW RNR. THE DEVICE PERFORMED AS EXPECTED AND PATIENT IS DOING WELL.

  Patient problems: Failure of Implant; Therapeutic Response, Decreased

  MAUDE report 7958255 ↗
• MalfunctionSep 5, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2018, PATIENT (B)(6) AT THE UNIVERSITY (B)(6) WAS UNABLE TO CHARGE THE DEVICE AND HAD A FLASHING RED LIGHT ON THE MC. THE RESHAPE LIFESCIENCES FIELD SPECIALIST CONNECTED HER TO THE CP AND ALARM CODES #4 AND #25 WERE OBSERVED. THESE ALARMS WERE CLEARED AND THE FLASHING RED LIGHT DISAPPEARED. THE CP CONTINUED TO ASK TO START A CHARGE AS THE RNR BATTERY WAS EXTREMELY LOW. AFTER ABOUT 15 MINUTES OF CHARGING USING THE PATIENTS MC, THERAPY WAS ABLE TO BE ADJUSTED AND A LIVE TEST PERFORMED. ON-DEMAND IMPEDANCE MEASUREMENT WAS PERFORMED AND THE RESULTS WERE AS FOLLOWS: 934, 1033, 677. BEFORE THE PATIENT LEFT, ANOTHER ON-DEMAND IMPEDANCE TEST WAS PERFORMED, THE READINGS WERE AS FOLLOWS: 821, 1062, 0. A RED FLASHING LIGHT WAS OBSERVED ON THE MC. THE PATIENT WAS HOOKED UP TO THE CP TO CLEAR THE RED LIGHT AND WAS SENT HOME. ON (B)(6) 2018, THE PATIENT INDICATED THEY RECEIVED ANOTHER FLASHING RED LIGHT.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 7848028 ↗
• MalfunctionAug 17, 2018Battery Problem: Low Impedance; Battery Problem: Low Impedance

  PATIENT SUBJECT (B)(6) AT (B)(6) WHO WAS ORIGINALLY AN EMPOWER PATIENT AND HAS CONVERTED TO THE RECHARGEABLE SYSTEM. THE PATIENT WAS EXPERIENCING A FLASHING RED LIGHT ON THEIR MC. RESHAPE'S FIELD SPECIALIST MET THE PATIENT ON (B)(4) 2018. WHEN CONNECTED TO THE CP, ERROR CODES #25 AND #4 WERE DISPLAYED AND CLEARED. THE ON DEMAND IMPEDANCES WERE AS FOLLOWS: 954, 1198, 795, AND 804, 735, 6548. THE THERAPY WAS RESTARTED. A LIVE TEST WAS PERFORMED AND THE PATIENT WAS SENT HOME RECEIVING THERAPY. ON MAY 18, 2018, RESHAPE RECEIVED ADDITIONAL INFORMATION WHEN THE FIELD SPECIALIST VISITED THE SITE. AFTER REVIEWING THE LOGS, THE PATIENT RECEIVED THERAPY FOR 13 DAYS BEFORE A LOW IMPEDANCE ALARM WAS TRIGGERED. THE CP CLEARED THE ALARMS AND ON DEMAND IMPEDANCE MEASUREMENTS WERE PERFORMED AS FOLLOWED: 960, 1211, 781 AND 967, 1241, 781. ANOTHER LIVE TEST WAS PERFORMED AND THE PATIENT WAS SENT HOME RECEIVING THERAPY.

  Patient problems: No Known Impact Or Consequence To Patient; Therapeutic Response, Decreased

  MAUDE report 7795492 ↗
• InjuryJul 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN REPORTED PATIENT (B)(6) HAD AN RNR POCKET INFECTION. THE PHYSICIAN TREATED THE PATIENT WITH ANTIBIOTICS AND THEY RESPONDED POSITIVE CLINICALLY; HOWEVER, WHEN THE PHYSICIAN TAKES THE PATIENT OFF ANTIBIOTICS, THE INFECTION FLARES UP. THEREFORE, THE PATIENT AND THE PHYSICIAN DECIDED TO EXPLANT THE DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 7691289 ↗
• MalfunctionApr 26, 2018Device Inoperable; Visual Prompts will not Clear; Device Displays Incorrect Message; Therapeutic or Diagnostic Output Failure; Device Inoperable; Visual Prompts will not Clear; Device Displays Incorrect Message; Therapeutic or Diagnostic Output Failure

  THE DEVICE WAS IMPLANTED ON (B)(6) 2016. THE RNR HAD A FLASHING RED LIGHT DURING IMPLANTATION, HALF-WAY THROUGH PATIENT REGISTRATION WITH THE CP. THE RNR WAS REPLACED AND THE CASE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7466433 ↗
• MalfunctionApr 26, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  THE RNR WAS IMPLANTED ON (B)(6) 2016, THE DISSECTION AND LEAD PLACEMENT WENT WELL. THE LEADS WERE CONNECTED TO THE RNR AND INITIAL IMPEDANCE MEASUREMENTS WERE 688, 883, AND 953. THERAPY WAS THEN ACTIVATED. BEFORE A LIVE TEST COULD BE PERFORMED, THE CP DISPLAYED ERROR CODE #14, REGULATOR HV VOLTAGE ABOVE MAX THRESHOLD. THE ERROR CODE BOX WAS CLOSED AND THEN THE CP IMMEDIATELY ENDED THE SESSION. THE RESHAPE CLINICAL FIELD SPECIALIST ATTEMPTED TO RECONNECT THE RNR THREE MORE TIMES AND THE SAME ERROR MESSAGE WOULD APPEAR AND THEN CLOSE THE SESSION. A NEW RNR WAS REGISTERED AND IMPLANTED SUCCESSFULLY WITHOUT ANY ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7466427 ↗
• MalfunctionApr 26, 2018Device Inoperable; Visual Prompts will not Clear; Device Displays Incorrect Message; Therapeutic or Diagnostic Output Failure; Device Inoperable; Visual Prompts will not Clear; Device Displays Incorrect Message; Therapeutic or Diagnostic Output Failure

  ON (B)(6) 2016, DURING INITIAL PHASE OF SURGERY PRIOR TO OPENING THE DEVICE PACKAGING, A RESHAPE FIELD CLINICAL SPECIALIST WAS ATTEMPTING TO CHECK THE RNR BATTERY LEVEL AND STATUS USING THE SITE MC AND THE SITE'S PHYSICIAN COIL. A RED FLASHING STATUS LED WAS OBSERVED IMMEDIATELY. THE FIELD CLINICAL SPECIALIST OPENED A CP SESSION TO INTERROGATE RNR AND READ AN ALARM MESSAGE RELATING TO MAGNET SWIPE. THE FIELD CLINICAL SPECIALIST ATTEMPTED TO FOLLOW PROMPTS AND CLEAR ALARM, HOWEVER, THE CP FAILED TO CLEAR ALARM AND PRESENTED ADDITIONAL ERROR MESSAGE REGARDING THE REED SWITCH CLOSED AND INABILITY TO CORRECT ISSUE, INSTRUCTING USER TO CONTACT EMI. A NEW RNR WAS USED, THE CP WAS RESTARTED PRIOR TO INTERROGATING THE NEW RNR PER RECOMMENDED CP SHUTDOWN METHOD AND THE CASE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7466424 ↗
• InjuryFeb 23, 2018Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT SHE FEELS A ZAP IN THE RIGHT SIDE OF HER ABDOMEN WHICH RESULTS IN UNBEARABLE PAIN. SHE EXPERIENCES IT AT LEAST ONCE OR TWICE A WEEK AND THE EPISODES LAST FOR 20-30 MINS. SHE BELIEVES THAT IT IS RELATED TO THE IMPLANT AND LET THE BATTERY DIE COMPLETELY. SHE HASN'T RECEIVED THERAPY SINCE (B)(6) AND HASN'T HAD ONE OF THOSE EPISODES SINCE. THE PHYSICIAN FEELS THAT IT MIGHT NOT BE RELATED TO THE DEVICE BUT HAS SOMETHING TO DO WITH HER GALLBLADDER. THE PATIENT AGREED TO GIVE TRY AGAIN FOR 2 WEEKS SO THE DEVICE WAS RESTARTED. THE DEVICE WAS RECHARGED, THERAPY WAS ADJUSTED TO 10 HOURS PER DAY, AND THE PATIENT WAS TRAINED HOW TO TURN THE DEVICE OFF IN CASE THE PAIN RETURNS. THE PATIENT RETURNED APPROXIMATELY 2 WEEKS LATER WITH THE SAME ISSUE. SHE HAD ONE OF THOSE EPISODES ON THE SAME DAY WE TURNED HER DEVICE BACK ON. SHE FEELS THAT THE DEVICES MAKES HER EXTREMELY GASSY AND BLOATED ALSO. THE DEVICE WAS TURNED OFF. THE PATIENT WANTS TO WAIT AND WATCH FOR A MONTH TO SEE IF THERE IS ANY IMPROVEMENT.

  Patient problems: Abdominal Pain; Shock from Patient Lead(s)

  MAUDE report 7293913 ↗
• MalfunctionJan 11, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  THIS PATIENT UNDERWENT IMPLANTATION OF THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2017. HIGH IMPEDANCE READINGS WERE RECEIVED AFTER CONNECTION OF THE RECHARGEABLE NEUROREGULATOR AND APPLICATION OF MEDICAL ADHESIVE. TWO ERROR CODES WERE THEN RECEIVED: CODE 10 (THERAPY DIAGNOSTIC FAILURE) AND CODE 30 (SAFETY CHECK FAILED). THE RECHARGEABLE NEUROREGULATOR (RNR) WAS REMOVED DURING THIS SAME PROCEDURE AND REPLACED WITH ANOTHER RNR WITHOUT INCIDENT. IMPEDANCE MEASUREMENTS FOLLOWING REPLACEMENT OF THE RNR WERE WITHIN NORMAL RANGE.

  Patient problems: Failure of Implant

  MAUDE report 7185079 ↗
• MalfunctionJan 9, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  WHILE INTERROGATING THE RECHARGEABLE NEUROREGULATOR DEVICE PRIOR TO IMPLANT, A RED STATUS LED WAS DISPLAYED WHEN ATTEMPTING TO CHECK THE BATTERY STATUS. THE ERROR CONDITION WAS CHECKED WHICH INDICATED A MAGNET SWIPE SHUTDOWN HAD OCCURRED. THE FIELD CLINICIAN ENGINEER DECIDED NOT USE THIS DEVICE AND PROCEEDED WITH A BACK UP UNIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7176223 ↗
• InjuryDec 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT WAS IMPLANTED WITH THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT VISITED THE EMERGENCY ROOM AND WAS TREATED FOR APPARENT INFECTION WITH IV ANTIBIOTICS. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL, BUT WAS SENT HOME THE SAME DAY ON ORAL ANTIBIOTICS (BACTRIUM). PATIENT WAS ON BACTRIUM FROM (B)(6) 2016 THROUGH (B)(6) 2017. AT A CLINIC VISIT ON (B)(6) 2017, THE INCISION WAS REPORTED TO APPEAR AS IF IT WAS HEALING NORMALLY. NO FURTHER REPORTS HAVE BEEN RECEIVED FOR THIS PATIENT. THIS MDR COVERS INVESTIGATION OF THE RECHARGEABLE NEUROREGULATOR. REFER TO MDR3005025697-2017-00025 FOR REPORT OF THE ANTERIOR LEAD AND MDR3005025697-2017-00026 FOR REPORT OF THE POSTERIOR LEAD.

  Patient problems: Unspecified Infection

  MAUDE report 7116892 ↗
• MalfunctionOct 18, 2017Failure to Charge; Device Operates Differently Than Expected; Failure to Charge; Device Operates Differently Than Expected

  THIS PATIENT WAS IMPLANTED WITH THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2017. THIS SUBJECT HAS REPORTED ISSUES CHARGING THE IMPLANTED RECHARGEABLE NEUROREGULATOR. USING A CHARGED MOBILE CHARGER, COMMUNICATION REQUIRED FOR CHARGING COULD NOT BE MAINTAINED. UPON DEVICE INTERROGATION, NO ALARMS OR ERROR CODES WERE NOTED. AN ALARM CLEARING SEQUENCE WAS RUN DURING A CLINIC VISIT ON (B)(6) 2017. FOLLOWING THIS, A CHARGE WAS SUCCESSFULLY INITIATED. PATIENT LEFT THE CLINIC RECEIVING THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6958720 ↗
• MalfunctionOct 18, 2017Failure to Charge; Device Operates Differently Than Expected; Failure to Charge; Device Operates Differently Than Expected

  THIS PATIENT WAS IMPLANTED WITH THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2017. THIS SUBJECT HAS REPORTED ISSUES CHARGING THE IMPLANTED RECHARGEABLE NEUROREGULATOR. USING A CHARGED MOBILE CHARGER, COMMUNICATION REQUIRED FOR CHARGING COULD NOT BE MAINTAINED. UPON DEVICE INTERROGATION, NO ALARMS OR ERROR CODES WERE NOTED. AN ALARM CLEARING SEQUENCE WAS RUN DURING A CLINIC VISIT ON (B)(6) 2017. FOLLOWING THIS, A CHARGE WAS SUCCESSFULLY INITIATED. PATIENT LEFT THE CLINIC RECEIVING THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6958717 ↗
• MalfunctionApr 19, 2017Device Inoperable; Visual Prompts will not Clear; Device Displays Incorrect Message; Therapeutic or Diagnostic Output Failure; Device Inoperable; Visual Prompts will not Clear; Device Displays Incorrect Message; Therapeutic or Diagnostic Output Failure

  THIS PATIENT UNDERWENT IMPLANTATION OF THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2015. AN UNANTICIPATED SHUTDOWN EVENT OF THE RECHARGEABLE NEUROREGULATOR (RNR) WAS REPORTED ON (B)(6) 2017. MULTIPLE ATTEMPTS TO RESET THE REAL TIME CLOCK, CLEAR THE UNINTENDED SHUTDOWN ERROR CODE, AND RECONNECT THE BATTERY IN THE RNR WERE UNSUCCESSFUL. THERAPY DELIVERY COULD NOT BE RE-ESTABLISHED.

  Patient problems: Failure of Implant; Therapeutic Response, Decreased

  MAUDE report 6504798 ↗
• InjuryMar 1, 2017Device Inoperable; Use of Device Problem; Low impedance; Device Displays Incorrect Message; Impedance Problem; Device Inoperable; Use of Device Problem; Low impedance; Device Displays Incorrect Message; Impedance Problem

  A FORMER SUBJECT IN THE EMPOWER CLINICAL TRIAL ((B)(4); SUBJECT ID (B)(6)) WAS ORIGINALLY CONVERTED TO A MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2015. THE SYSTEM, INCLUDING MODEL 2002 RECHARGEABLE NEUROREGULATOR, MODEL 2200A-47E ANTERIOR LEAD, AND MODEL 2200P-47E POSTERIOR LEAD WERE REPLACED ON (B)(6) 2016 (REFER TO MDR3005025697-2017-00005 THROUGH MDR3005025697-2017-00007 FOR DETAILS ON ORIGINAL RECHARGEABLE SYSTEM REMOVAL DUE TO EXCESSIVE MANIPULATION). ON (B)(6) 2016, THE SITE REPORTED THAT ALERTS FOR LOW IMPEDANCE WERE EXPERIENCED AT FOLLOW-UP, NOTING THAT THE RING ELECTRODES WERE PLACED QUITE CLOSE TOGETHER AT IMPLANT. ON (B)(6) 2016, IT WAS REPORTED THAT LOW IMPEDANCE MEASUREMENTS WERE AGAIN EXPERIENCED. RADIOGRAPH REVIEW SUGGESTED THAT THE RING ELECTRODES WERE IN VERY CLOSE PROXIMITY TO EACH OTHER WITH TWISTING OF THE LEADS NEAR THE NEUROREGULATOR. THE REPLACEMENT SYSTEM WAS EXPLANTED ON (B)(6) 2016. MDRS RELATED TO THIS ISSUE ARE: MDR3005025697-2017-00008: MODEL 2002 RECHARGEABLE NEUROREGULATOR. MDR3005025697-2017-00009: MODEL 2200A-47E ANTERIOR LEAD. MDR3005025697-2017-00010: MODEL 2200P-47E POSTERIOR LEAD.

  Patient problems: Failure of Implant; Therapeutic Response, Decreased; Twiddlers Syndrome

  MAUDE report 6370106 ↗
• InjuryMar 1, 2017Electrical /Electronic Property Problem; Device Inoperable; Use of Device Problem; Low impedance; Device Displays Incorrect Message; Impedance Problem; Electrical /Electronic Property Problem; Device Inoperable; Use of Device Problem; Low impedance; Device Displays Incorrect Message; Impedance Problem

  A FORMER SUBJECT IN THE (B)(6) WAS CONVERTED TO A MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2015. AT THE CONVERSION PROCEDURE, THE ORIGINAL INVESTIGATIONAL RF NEUROREGULATOR WAS REPLACED WITH THE COMMERCIAL MODEL 2002 RECHARGEABLE NEUROREGULATOR. THE ANTERIOR AND POSTERIOR LEADS, IMPLANTED AS PART OF THE (B)(6) CLINICAL TRIAL ON (B)(6) 2008, WERE NOT REPLACED AT THE TIME OF CONVERSION TO THE RECHARGEABLE SYSTEM. ON (B)(6) 2015 THE SITE REPORTED THAT THIS PATIENT WAS EXPERIENCING LOW IMPEDANCE OF THE ANTERIOR LEAD WITH RELATED ERROR CODES. THERAPY WAS RESTARTED BUT THEN THIS ISSUE RETURNED. REVIEW OF RADIOGRAPH IMAGES SUGGEST THAT THIS ISSUE WAS CAUSED BY EXCESSIVE DEVICE MANIPULATION BY THE PATIENT. THE SYSTEM, INCLUDING MODEL 2002 RECHARGEABLE NEUROREGULATOR, MODEL 2200A-47E ANTERIOR LEAD, AND MODEL 2200P-47E POSTERIOR LEAD WERE REPLACED ON (B)(6) 2016. MDRS RELATED TO THIS ISSUE ARE: MDR3005025697-2017-00005: MODEL 2002 RECHARGEABLE NEUROREGULATOR; MDR3005025697-2017-00006: MODEL 2200A-47E ANTERIOR LEAD; MDR3005025697-2017-00007: MODEL 2200P-47E POSTERIOR LEAD.

  Patient problems: Failure of Implant; Therapeutic Response, Decreased; Twiddlers Syndrome

  MAUDE report 6370095 ↗
• MalfunctionJan 10, 2017Electrical /Electronic Property Problem; Device Displays Incorrect Message; Electrical /Electronic Property Problem; Device Displays Incorrect Message

  THIS RECHARGE CLINICAL TRIAL SUBJECT WAS IMPLANTED WITH THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2011. THIS SUBJECT HAS EXPERIENCED SEVERAL MAGNET SWIPE DEACTIVATIONS OF THE IMPLANTED RECHARGEABLE NEUROREGULATOR, THAT WERE INITIALLY REPORTED ON (B)(6) 2016. ON (B)(6) 2016 ADDITIONAL INFORMATION WAS RECEIVED INDICATING MULTIPLE ADDITIONAL UNANTICIPATED DEACTIVATIONS OF THE RNR ON (B)(6) 2016 WITH NO ASSOCIATED MAGNET DEACTIVATION CODE. AT LAST REPORT, THIS SUBJECT IS CURRENTLY RECEIVING THERAPY FROM THE IMPLANTED DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 6237405 ↗
• MalfunctionDec 1, 2016Electrical /Electronic Property Problem; Device Inoperable; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Electrical /Electronic Property Problem; Device Inoperable; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT WAS IMPLANTED WITH THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2016. PATIENT WAS UNABLE TO CHARGE THEIR RECHARGEABLE NEUROREGULATOR (RNR) FOR AN EXTENDED PERIOD OF TIME DUE TO AN ISSUE WITH AN EXTERNAL SYSTEM COMPONENT. THIS RESULTED IN DISCONNECTION OF THE RNR BATTERY AND DISCONTINUATION OF THERAPY. DURING A CLINIC VISIT TO RECONNECT THE RNR BATTERY ON (B)(6) 2016, A CHARGE OF THE RNR BATTERY COULD NOT BE INITIATED. THE RNR WENT FROM THE APPLICATION MODE INTO THE BOOTLOADER MODE OF OPERATION AND A BROWNOUT CODE WAS ENCOUNTERED. AN UNEXPECTED RESPONSE CODE (NAK) WAS RECEIVED. THE RNR BATTERY COULD NOT BE RECONNECTED AND THERAPY COULD NOT BE RESTARTED.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient; Therapeutic Response, Decreased

  MAUDE report 6137999 ↗
• InjuryDec 1, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT WAS IMPLANTED WITH THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2016. ON NOVEMBER 3, 2016, IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING PAIN AT THE SITE OF THE IMPLANTED RECHARGEABLE NEUROREGULATOR (RNR) AND REQUESTED DEVICE EXPLANT. THE MAESTRO RECHARGEABLE SYSTEM WAS REPORTED TO HAVE BEEN SUBSEQUENTLY EXPLANTED WITHOUT INCIDENT ON (B)(6) 2016. NO INFECTION WAS REPORTED. PAIN AT THE RNR SITE IS A KNOWN POSSIBLE EFFECT OF DEVICE IMPLANTATION INCLUDED IN DEVICE LABELING.

  Patient problems: Pain

  MAUDE report 6137998 ↗
• MalfunctionOct 5, 2016Electrical /Electronic Property Problem; Device Displays Incorrect Message; Electrical /Electronic Property Problem; Device Displays Incorrect Message

  THIS PATIENT WAS IMPLANTED WITH THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT NOTICED A FLASHING LIGHT ON THE DEVICE DURING AN ATTEMPTED CHARGE SESSION AND WENT TO THE CLINIC ON (B)(6) 2016. A FLASHING LIGHT AGAIN APPEARED FOLLOWING POSITIONING OF THE TRANSMIT COIL. REVIEW OF DEVICE LOG DATA INDICATES THAT AN UNEXPECTED SHUTDOWN OF THE RECHARGEABLE NEUROREGULATOR OCCURRED ON (B)(6) 2016. THERAPY WAS RE-STARTED ON (B)(6) 2016.

  Patient problems: Failure of Implant; Therapeutic Response, Decreased

  MAUDE report 6000068 ↗
• InjurySep 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, A SUBJECT PARTICIPATING IN THE RECHARGE CLINICAL TRIAL (SUBJECT (B)(6)), UNDERWENT INITIAL IMPLANTATION OF THE MAESTRO RECHARGEABLE SYSTEM. ON (B)(6) 2016, THIS SUBJECT UNDERWENT A REVISION PROCEDURE UNDER GENERAL ANESTHESIA TO REPOSITION THE NEUROREGULATOR DUE TO DISCOMFORT CAUSED BY THE NEUROREGULATOR POSITION NEAR THE BRA LINE. THE REPOSITIONING PROCEDURE WAS UNEVENTFUL AND THE DEVICE CONTINUED TO WORK WELL AFTER SURGERY. THERE WERE NO COMPLICATIONS AND THE SUBJECT WAS DISCHARGED TO HOME THE SAME DAY. ON (B)(6) 2016, THE SUBJECT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION DUE TO SEVERE PAIN AT THE NEUROREGULATOR SITE. CT REVEALED A HEMATOMA ON THE LEFT SIDE OF THE ABDOMINAL AND CHEST WALL. THERE WAS NO SIGN OF ACTIVE BLEEDING AND THE SUBJECT WAS IN STABLE CONDITION. THIS SUBJECT HAS A HISTORY OF TYPE 2 DIABETES MELLITUS AND OBSTRUCTIVE SLEEP APNEA. DURING THE HOSPITAL STAY, BLOOD GLUCOSE LEVELS WERE ELEVATED (250-300'S) AND ENDOCRINOLOGY EVALUATION AND FOLLOW-UP WERE COMPLETED. CPAP AT NIGHT AND SUPPLEMENTAL OXYGEN VIA NC (4L) WERE USED FOR SPO2 89-90 (NORMAL<95-100%). THE SUBJECT HAS A HISTORY OF ASTHMA AND SMOKES 1 PACK PER DAY. THE PAIN WAS MANAGED WITH NORCO

  Patient problems: Abdominal Pain; Bruise/Contusion; Chills; Diaphoresis; Erythema; Fever; Hematoma; Nausea; Post Operative Wound Infection; Swelling; Tachycardia

  MAUDE report 5971754 ↗
• MalfunctionJul 6, 2016Device Stops Intermittently; Device Displays Incorrect Message; Device Stops Intermittently; Device Displays Incorrect Message

  PATIENT WAS SEEN IN CLINIC APPROXIMATELY 2 WEEKS AFTER IMPLANT OF THE MAESTRO RECHARGEABLE SYSTEM. UPON INITIAL DEVICE INTERROGATION, THE ALARM CODE INDICATING THE IMPLANTED DEVICE HAD BEEN SHUT DOWN DUE TO A MAGNET SWIPE. THE PATIENT DID NOT RECALL BEING NEAR ANY STRONG MAGNETS. THERAPY WAS RESTARTED. DURING THE WEEK OF (B)(6) 2016, IT WAS AGAIN REPORTED THAT THE DEVICE WAS AGAIN SHUT DOWN WITH ALARM CODE INDICATING THIS WAS DUE TO A MAGNET SWIPE. THERAPY WAS AGAIN RESTARTED WITHOUT ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem; Therapeutic Response, Decreased

  MAUDE report 5772692 ↗
• MalfunctionJun 22, 2016Device Inoperable; Device Displays Incorrect Message; Device Inoperable; Device Displays Incorrect Message

  DURING INITIAL IMPLANT OF MAESTRO RECHARGEABLE SYSTEM, COMMUNICATION WITH THE RECHARGEABLE NEUROREGULATOR (RNR) WAS LOST. THE PHYSICIAN ATTEMPTED TO RESOLVE THIS BY TURNING OFF AND RE-STARTING THE EXTERNAL CLINICIAN PROGRAMMER. COMMUNICATION COULD NOT BE RE-ESTABLISHED WITH THE RNR. THE RNR WAS REPLACED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 5743806 ↗
• MalfunctionJun 17, 2016Device Inoperable; Device Displays Incorrect Message; Device Inoperable; Device Displays Incorrect Message

  DURING INITIAL IMPLANT OF MAESTRO RECHARGEABLE SYSTEM, HIGH INITIAL IMPEDANCE MEASUREMENTS WERE OBTAINED (765, >65,999, >65,999 OHM). THE PHYSICIAN ATTEMPTED TO RESOLVE THIS BY RE-INSERTING THE LEAD CONNECTORS IN THE HEADER OF THE RECHARGEABLE NEUROREGULATOR (RNR). THE ERROR CODE "UNINTENDED SHUTDOWN" WAS THEN ENCOUNTERED, LOSING COMMUNICATION WITH THE RECHARGEABLE NEUROREGULATOR. COMMUNICATION COULD NOT BE RE-ESTABLISHED WITH THE RNR. AFTER CONFIRMING THAT THE ISSUE WAS NOT RELATED TO EXTERNAL EQUIPMENT, THE RNR WAS REPLACED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 5734211 ↗