Model 2200A-47E Maestro Anterior LeadRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00857334004286), received between Oct 29, 2015 and Dec 14, 2017 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ANTERIOR LEAD. REFER TO MDR 3005025697-2017-00024 FOR REPORT OF THE RECHARGEABLE NEUROREGULATOR AND MDR 3005025697-2017-00026 FOR REPORT OF THE POSTERIOR LEAD.

  Patient problems: Unspecified Infection

  MAUDE report 7116896 ↗
• MalfunctionAug 16, 2017High impedance; Device Inoperable; Therapeutic or Diagnostic Output Failure; High impedance; Device Inoperable; Therapeutic or Diagnostic Output Failure

  HIGH IMPEDANCE OF THE ANTERIOR LEAD WAS EXPERIENCED DURING AN INITIAL IMPLANT PROCEDURE OF THE MAESTRO RECHARGEABLE SYSTEM IN THIS PATIENT. THE ANTERIOR LEAD WAS REPLACED DURING THE SAME PROCEDURE RESULTING IN IMPEDANCE VALUES WITHIN THE ACCEPTABLE RANGE AND SUCCESSFUL ACTIVATION OF THERAPY. THE INITIAL ANTERIOR LEAD THAT RESULTED IN HIGH IMPEDANCE MEASUREMENTS WAS RETURNED FOR ANALYSIS. HIGH IMPEDANCE OF THE POSTERIOR LEAD WAS ALSO EXPERIENCED DURING THIS PROCEDURE. REFER TO MDR 3005025697-2017-00018 FOR REPORT OF THE POSTERIOR LEAD.

  Patient problems: Failure of Implant

  MAUDE report 6798639 ↗
• MalfunctionAug 16, 2017High impedance; High impedance

  HIGH IMPEDANCE OF THE ANTERIOR LEAD WAS EXPERIENCED DURING AN INITIAL IMPLANT PROCEDURE OF THE MAESTRO RECHARGEABLE SYSTEM IN THIS PATIENT. THE ANTERIOR LEAD WAS REPLACED DURING THE SAME PROCEDURE RESULTING IN IMPEDANCE VALUES WITHIN THE ACCEPTABLE RANGE AND SUCCESSFUL ACTIVATION OF THERAPY. THE INITIAL ANTERIOR LEAD THAT RESULTED IN HIGH IMPEDANCE MEASUREMENTS WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6798628 ↗
• MalfunctionAug 16, 2017High impedance; Device Inoperable; Therapeutic or Diagnostic Output Failure; High impedance; Device Inoperable; Therapeutic or Diagnostic Output Failure

  HIGH IMPEDANCE OF THE ANTERIOR LEAD WAS EXPERIENCED DURING AN INITIAL IMPLANT PROCEDURE OF THE MAESTRO RECHARGEABLE SYSTEM IN THIS PATIENT. THE ANTERIOR LEAD WAS REPLACED DURING THE SAME PROCEDURE RESULTING IN IMPEDANCE VALUES WITHIN THE ACCEPTABLE RANGE AND SUCCESSFUL ACTIVATION OF THERAPY. THE INITIAL ANTERIOR LEAD THAT RESULTED IN HIGH IMPEDANCE MEASUREMENTS WAS RETURNED FOR ANALYSIS.

  Patient problems: Failure of Implant

  MAUDE report 6798620 ↗
• 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

  SUBJECT PARTICIPATING IN THE (B)(6) REPORTED A FLASHING RED LIGHT ON (B)(6) 2017. DURING A CLINIC VISIT ON (B)(6) 2017, MULTIPLE ERROR CODE MESSAGES WERE REPORTED INCLUDING 12 (PULSE CURRENT BELOW MINIMUM THRESHOLD), 3 (HIGH IMPEDENCE FOR 60 MINUTES), AND 25 (TOO MANY THERAPY RETRIES). ANTERIOR LEAD TIP TO RING AND ANTERIOR TIP TO POSTERIOR TIP IMPEDANCE READINGS OF >65 KOHMS WERE ALSO REPORTED, INDICATING AN OPEN CIRCUIT. THERAPY COULD NOT BE RE-STARTED.

  Patient problems: Failure of Implant; Therapeutic Response, Decreased

  MAUDE report 6504794 ↗
• InjuryMar 1, 2017Device Inoperable; Use of Device Problem; Low impedance; Device Displays Incorrect Message; Impedance Problem; Material Twisted/Bent; Device Inoperable; Use of Device Problem; Low impedance; Device Displays Incorrect Message; Impedance Problem; Material Twisted/Bent

  A FORMER SUBJECT IN THE (B)(6) CLINICAL TRIAL (IDE G070025; SUBJECT (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 THE 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 ISSUES 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 6370134 ↗
• InjuryMar 1, 2017Device Inoperable; Use of Device Problem; Low impedance; Device Displays Incorrect Message; Impedance Problem; Material Twisted/Bent; Device Inoperable; Use of Device Problem; Low impedance; Device Displays Incorrect Message; Impedance Problem; Material Twisted/Bent

  A FORMER SUBJECT IN THE (B)(6) CLINICAL TRIAL (IDE (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 MDR 3005025697-2017-00005 THROUGH MDR 3005025697-2017-00007 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 PLACES 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. MDR'S RELATED TO THIS ISSUES ARE: MDR 3005025697-2017-00008: MODEL 2002 RECHARGEABLE NEUROREGULATOR, MDR 3005025697-2017-00009: MODEL 2200A-47E ANTERIOR LEAD, MDR 3005025697-2017-00010: MODEL 2200P-47E POSTERIOR LEAD.

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

  MAUDE report 6370103 ↗
• MalfunctionFeb 9, 2017Electrical /Electronic Property Problem; Device Inoperable; Low impedance; Device Displays Incorrect Message; Electrical /Electronic Property Problem; Device Inoperable; Low impedance; Device Displays Incorrect Message

  SUBJECT PARTICIPATING IN THE (B)(6). THIS SUBJECT WAS IMPLANTED WITH THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2011. DURING A CLINIC VISIT ON (B)(6) 2016, ERROR CODES WERE RECEIVED FOR LOW IMPEDANCE OF THE ANTERIOR LEAD AND TOO MANY THERAPY RETRIES. ALARMS WERE CLEARED AND THERAPY RESUMED. THERAPY WAS AGAIN INTERRUPTED FROM (B)(6) 2016. DURING A CLINIC VISIT ON (B)(6) 2016, THE SAME ERROR CODES AS OCCURED ON (B)(6) 2016 WERE CLEARED AND THERAPY WAS RESUMED. ON (B)(6) 2017 AN ANTERIOR TIP TO ANTERIOR RING SHORT WAS EXPERIENCED AGAIN. THE DEVICE WAS EXPLANTED ON (B)(6) 2017. EXTREME SCARRING AND ADHESIONS WERE NOTED AT EXPLANT. HOWEVER, THE ENTIRE DEVICE WAS ABLE TO BE EXPLANTED.

  Patient problems: Failure of Implant; Therapeutic Response, Decreased

  MAUDE report 6316569 ↗
• MalfunctionJan 10, 2017Failure to Conduct; Disconnection; Electrical /Electronic Property Problem; High impedance; Device Inoperable; Device Displays Incorrect Message; Material Distortion; Material Twisted/Bent; Failure to Conduct; Disconnection; Electrical /Electronic Property Problem; High impedance; Device Inoperable; Device Displays Incorrect Message; Material Distortion; Material Twisted/Bent

  THIS SUBJECT IS A PARTICIPANT IN THE RECHARGE CLINICAL TRIAL. THIS SUBJECT WAS ORIGINALLY IN THE CONTROL ARM OF THE TRIAL AND UNDERWENT IMPLANTATION OF THE ACTIVE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2014. SUBJECT NOTICED A FLASHING RED LIGHT THAT WAS REPORTED ON (B)(6) 2016. DURING A CLINIC VISIT ON (B)(6) 2016, IT WAS REPORTED THAT THE SUBJECT HAS AN OPEN CIRCUIT OF THE IMPLANTED ANTERIOR LEAD. THERAPY IS NOT BEING DELIVERED. SUPPLEMENT 001: SUBJECT UNDERWENT REVISION OF THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2017. BECAUSE THE ANTERIOR LEAD WAS TWISTED WITH THE POSTERIOR LEAD, ALL DEVICE COMPONENTS WERE REPLACED. REVISION PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ADVERSE IMPACT TO SUBJECT. EXPLANTED DEVICE COMPONENTS HAVE NOT YET BEEN RECEIVED BY ENTEROMEDICS. REFERENCE MDR 3005025697-2017-00014 FOR REPORT RELATED TO THE POSTERIOR LEAD. SUPPLEMENT 002: EXPLANTED DEVICE COMPONENTS RECEIVED ON (B)(6) 2017.

  Patient problems: Failure of Implant; Therapeutic Response, Decreased

  MAUDE report 6237397 ↗
• MalfunctionDec 1, 2016Electrical /Electronic Property Problem; High impedance; Device Inoperable; Device Displays Incorrect Message; Electrical /Electronic Property Problem; High impedance; Device Inoperable; Device Displays Incorrect Message

  (B)(6) SUBJECT PARTICIPATING IN (B)(6) WAS IMPLANTED WITH THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2011. DURING A CLINIC VISIT ON (B)(6) 2016, IT WAS DETERMINED THAT A SHORT CIRCUIT OF THE ANTERIOR LEAD HAD BEEN EXPERIENCED ON (B)(6) 2016 AND AN ANTERIOR LEAD OPEN CIRCUIT WAS EXPERIENCED ON (B)(6) 2016. THIS SUBJECT FIRST REPORTED A FLASHING RED LIGHT ON THE MOBILE CHARGER DURING THE CLINIC VISIT ON (B)(6) 2016. DURING THIS VISIT, ALARMS WERE NOTED FOR LOW RNR BATTERY, THE ANTERIOR TIP TO RING SHORT CIRCUIT, AND THE ANTERIOR LEAD OPEN CIRCUIT. THERAPY WAS RE-STARTED AT THIS VISIT, AND ALARMS WERE CLEARED. RED LIGHT WAS REPORTED BY SUBJECT TO HAVE RETURNED ON (B)(6) 2016. DURING AN ADDITIONAL CLINIC VISIT ON (B)(6) 2016, ALARM CODE 3 (IMPEDANCE HIGH) WAS ENCOUNTERED. DIAGNOSTIC EVALUATION REPORTED BY THE SITE INCLUDED ANOTHER ANTERIOR LEAD TIP TO RING OPEN CIRCUIT ON (B)(6) 2016. UPDATE: DEVICE WAS EXPLANTED ON (B)(6) 2016. EXTENSIVE ADHESIONS WERE NOTED DURING THE EXPLANT. THE ENTIRE MAESTRO RECHARGEABLE SYSTEM WAS REMOVED.

  Patient problems: Adhesion(s); Failure of Implant; Therapeutic Response, Decreased

  MAUDE report 6137994 ↗
• MalfunctionJun 17, 2016Low impedance; Device Displays Incorrect Message; Low impedance; Device Displays Incorrect Message

  A FORMER SUBJECT IN THE (B)(6) CLINICAL TRIAL, WHOSE ORIGINAL INVESTIGATIONAL RADIO FREQUENCY SYSTEM (ANTERIOR LEAD, POSTERIOR LEAD, AND INVESTIGATIONAL RF NEUROREGULATOR) WAS IMPLANTED ON (B)(6) 2008, UNDERWENT CONVERSION TO THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2016. AT THE CONVERSION IMPLANT, THE POSTERIOR LEAD WAS REPLACED AND THE INVESTIGATIONAL RF NEUROREGULATOR WAS REPLACED WITH THE MODEL 2002 RECHARGEABLE NEUROREGULATOR (RNR). THE ORIGINAL ANTERIOR LEAD, IMPLANTED ON (B)(6) 2008, WAS NOT REPLACED. ON (B)(6) 2016, A LOW IMPEDANCE ALERT WAS ENCOUNTERED AND CLEARED. AT THIS TIME, THE TEST AMPLITUDE FOR HIS SYSTEM WAS INCREASED FROM 1 TO 3 MA, WHICH IS TYPICALLY DONE AT THE FIRST FOLLOW-UP VISIT. ON (B)(6) 2016, THE PATIENT EXPERIENCED A RED LIGHT WHEN ATTEMPTING TO CHARGE THE RNR. ON (B)(6) 2016, DURING A CLINIC VISIT, A LOW IMPEDANCE ALERT (CODE 4) AND ASSOCIATED TOO MANY THERAPY RETRIES ALERT (CODE 25) WERE ENCOUNTERED. THESE ALERTS WERE CLEARED AND THE RED LIGHT DID NOT RE-APPEAR DURING THE VISIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5734210 ↗
• InjuryMay 26, 2016Device Inoperable; Low impedance; Low Readings; Device Inoperable; Low impedance; Low Readings

  IT WAS REPORTED THAT DURING FINAL PLACEMENT OF THE NEUROREGULATOR FOR THE MAESTRO RECHARGEABLE SYSTEM, AN ALARM INDICATED LOW IMPEDANCE OF THE POSTERIOR LEAD. THE ALARM PREVENTED THE INITIATION OF THERAPY. THE PROCEDURE WAS COMPLETED TO THE POINT WHERE MEDICAL ADHESIVE COVERED THE LEAD CONNECTION ON THE NEUROREGULATOR; THEREFORE, BOTH THE NEUROREGULATOR AND POSTERIOR LEAD WERE REMOVED AND REPLACED WITH ALTERNATE COMPONENTS. IMPLANTATION OF ALTERNATE COMPONENTS RESOLVED THE LOW IMPEDANCE ALARMS. THE READING ON THE FINAL IMPEDANCE MEASUREMENTS WAS SOMEWHAT LOW, SO THE IMPEDANCE AMPLITUDE SETTING WAS NOT LOWERED AS TYPICALLY DONE AT IMPLANT. THERE WAS NO REPORT OF ANY ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT.

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

  MAUDE report 5683695 ↗
• InjuryMay 26, 2016Device Inoperable; Device Displays Incorrect Message; Device Inoperable; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING USE OF THE MAESTRO RECHARGEABLE SYSTEM, THERE WAS LOW IMPEDANCE OF THE ANTERIOR LEAD. IT WAS FURTHER REPORTED THAT A FLASHING RED LIGHT APPEARED ON THE MOBILE CHARGER FIRST NOTICED AROUND (B)(6) 2015. DURING A CLINIC VISIT ON (B)(6) 2015 ALARMS WERE CLEARED WITH TOO MANY THERAPY RETRIES AND NOTED LOW IMPEDANCE. ON (B)(6) 2015, THE PATIENT REPORTED A BRUISE OVER THE SITE OF THE IMPLANTED NEUROREGULATOR, WITH NO ASSOCIATED DISCOMFORT OR TRAUMA. ON (B)(6) 2015, THE PATIENT REPORTED THAT THE NEUROREGULATOR HEATED UP SOMETIME BETWEEN (B)(6) 2015 AND THE NEXT CHARGE SESSION. AT AN ADDITIONAL CLINIC VISIT ON (B)(6) 2015, AN ERROR CODE MESSAGE "PULSE CURRENT BELOW MINIMUM THRESHOLD" WAS REPORTED, AS WELL AS AN IMPEDANCE READING OF >65 KOHMS, INDICATING AN OPEN CIRCUIT. THERAPY COULD NOT BE RE-STARTED. IT WAS DETERMINED THAT AN EXPLANT AND REVISION PROCEDURE WERE REQUIRED.

  Patient problems: Failure of Implant

  MAUDE report 5683427 ↗
• InjuryMay 19, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  A SUBJECT PARTICIPATING IN THE (B)(6) TRIAL WAS UNDERGOING PLANNED CONVERSION TO THE COMMERCIAL MAESTRO RECHARGEABLE SYSTEM ON APRIL 21, 2016. PRIOR TO THE PROCEDURE, THE SUBJECT REPORTED NO COMPLAINTS. DURING THE CONVERSION PROCEDURE, LOW RING TO RING IMPEDANCE WAS EXPERIENCED. IT WAS DETERMINED THAT PORTIONS OF BOTH THE ANTERIOR AND POSTERIOR LEADS (INCLUDING BOTH TIP ELECTRODES, ONE SUTURE WING, AND ONE RING ELECTRODE), WHICH WERE ORIGINALLY IMPLANTED ON (B)(6) 2008, HAD ERODED INTO THE LUMEN OF THE PROXIMAL STOMACH. ALL DEVICE COMPONENTS WERE REMOVED. THE GASTROSTOMY CREATED BY THE REMOVAL OF THE LEAD BODIES WAS REPAIRED PER STANDARD PROCEDURE AND A DRAIN PLACED. THIS SUBJECT WAS NOT CONVERTED TO THE MAESTRO RECHARGEABLE SYSTEM. THE SUBJECT WAS HOSPITALIZED FOLLOWING THIS PROCEDURE AND DISCHARGED ON (B)(6) 2016 IN GOOD CONDITION. THE SUBJECT WAS RE-ADMITTED ON (B)(4) 2016 FOR NAUSEA, VOMITING AND CONSTIPATION. WHITE BLOOD CELL COUNT WAS 13. A CT WAS DONE WHICH SHOWED SMALL LOCULES OF GAS AND FLUID NEAR THE AREA OF THE GASTROSTOMY REPAIR, AS WELL AS SUBCUTANEOUS COLLECTION OF FLUID ON THE LEFT FLANK, LIKELY A SEROMA. AN ESOPHAGRAM SHOWED NO EVIDENCE OF LEAKAGE. THE SUBJECT WAS T

  Patient problems: Abdominal Pain; Constipation; Erosion; Internal Organ Perforation; Nausea; Perforation; Seroma; Vomiting

  MAUDE report 5667959 ↗
• MalfunctionOct 29, 2015Electrical /Electronic Property Problem; Fracture; Overheating of Device; Device Inoperable; Low impedance; Device Displays Incorrect Message

  SUBJECT PARTICIPATING IN THE RECHARGE CLINICAL TRIAL ((B)(6)) EXPERIENCED LOW IMPEDANCE OF ANTERIOR LEAD. SUBJECT FIRST REPORTED A FLASHING RED LIGHT ON THE MOBILE CHARGER DURING A CLINIC VISIT ON (B)(6), 2015, WHICH WAS FIRST NOTICED APPROXIMATELY (B)(6), 2015. DURING THIS VISIT, ALARMS WERE CLEARED FOR TOO MANY THERAPY RETRIES AND IMPEDANCE TOO LOW. ON (B)(6), 2015, UPON REQUEST FOR ADDITIONAL INFORMATION, THE SUBJECT REPORTED A BRUISE OVER THE SITE OF THE IMPLANTED NEUROREGULATOR, WITH NO ASSOCIATED DISCOMFORT OR TRAUMA. ON (B)(6), 2015, THE SUBJECT ALSO REPORTED THAT THE NEUROREGULATOR HAD HEATED UP SOME TIME BETWEEN (B)(6), 2015 AND THE NEXT CHARGE SESSION. AT AN ADDITIONAL CLINIC VISIT ON (B)(6), 2015, AN ERROR CODE MESSAGE "PULSE CURRENT BELOW MINIMUM THRESHOLD" WAS REPORTED, AS WELL AS AN IMPEDANCE READING OF >65 KOHMS, INDICATING AN OPEN CIRCUIT. THERAPY COULD NOT BE RE-STARTED AT THIS VISIT, IN ACCORDANCE WITH DEVICE DESIGN. FOLLOWING REVIEW OF REPORTS AND AVAILABLE DEVICE LOG DATA, SURGICAL REVISION OR EXPLANT WAS FIRST RECOMMENDED ON (B)(6), 2015. THEREFORE, THIS EVENT WAS THEN CONSIDERED TO BE A REPORTABLE EVENT. NO SERIOUS INJURY OR DEATH HAS BEEN EXPERIENCED, OR IS A

  Patient problems: Bruise/Contusion; Failure of Implant; Therapeutic Response, Decreased

  MAUDE report 5189671 ↗