Model 2200P-47E Maestro Posterior LeadRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00857334004293), received between Sep 25, 2015 and Dec 14, 2017 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (14 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 16 most recent of 16 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 (BACTRIM). PATIENT WAS ON BACTRIM FROM (B)(6) 2016 THROUGH (B)(6) (B)(6) 2017. AT A CLINIC VISIT ON 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 POSTERIOR LEAD. REFER TO MDR3005025697-2017-00024 FOR REPORT OF THE RECHARGEABLE NEUROREGULATOR AND MDR3005025697-2017-00025 FOR REPORT OF THE ANTERIOR LEAD.

  Patient problems: Unspecified Infection

  MAUDE report 7116898 ↗
• MalfunctionAug 23, 2017High impedance; Device Inoperable; High impedance; Device Inoperable

  HIGH IMPEDANCE OF THE POSTERIOR LEAD WAS EXPERIENCED DURING AN INITIAL IMPLANT PROCEDURE OF THE MAESTRO RECHARGEABLE SYSTEM IN THIS PATIENT. AFTER CONFIRMING THIS WAS NOT CAUSED BY THE CONNECTION OF THE LEAD TO THE NEUROREGULATOR, THE POSTERIOR LEAD WAS REPLACED DURING THE SAME PROCEDURE. THE REPLACEMENT POSTERIOR LEAD ALSO RESULTED IN HIGH IMPEDANCE SO WAS ALSO REPLACED AND THE PROCEDURE COMPLETED. BOTH POSTERIOR LEADS THAT RESULTED IN HIGH IMPEDANCE MEASUREMENTS WERE RETURNED FOR ANALYSIS. THIS MDR COVERS INVESTIGATION THE SECOND POSTERIOR LEAD THAT WAS REPLACED (SERIAL NUMBER (B)(4)). REFER TO MDR3005025697-2017-00020 FOR REPORT OF THE FIRST POSTERIOR LEAD THAT WAS REPLACED DURING THE PROCEDURE (SERIAL NUMBER (B)(4)).

  Patient problems: Failure of Implant

  MAUDE report 6814594 ↗
• MalfunctionAug 23, 2017High impedance; Device Inoperable; High impedance; Device Inoperable

  HIGH IMPEDANCE OF THE POSTERIOR LEAD WAS EXPERIENCED DURING AN INITIAL IMPLANT PROCEDURE OF THE MAESTRO RECHARGEABLE SYSTEM IN THIS PATIENT. AFTER CONFIRMING THIS WAS NOT CAUSED BY THE CONNECTION OF THE LEAD TO THE NEUROREGULATOR, THE POSTERIOR LEAD WAS REPLACED DURING THE SAME PROCEDURE. THE REPLACEMENT POSTERIOR LEAD ALSO RESULTED IN HIGH IMPEDANCE SO WAS ALSO REPLACED AND THE PROCEDURE COMPLETED. BOTH POSTERIOR LEADS THAT RESULTED IN HIGH IMPEDANCE MEASUREMENTS WERE RETURNED FOR ANALYSIS. THIS MDR COVERS INVESTIGATION OF THE FIRST POSTERIOR LEAD THAT WAS REPLACED (SERIAL NUMBER (B)(4)). REFER TO MDR3005025697-2017-00021 FOR REPORT OF THE SECOND POSTERIOR LEAD THAT WAS REPLACED DURING THE PROCEDURE (SERIAL NUMBER (B)(4)).

  Patient problems: Failure of Implant

  MAUDE report 6814585 ↗
• MalfunctionAug 23, 2017High impedance; Device Inoperable; Device Displays Incorrect Message; Therapeutic or Diagnostic Output Failure; High impedance; Device Inoperable; Device Displays Incorrect Message; Therapeutic or Diagnostic Output Failure

  THIS PATIENT EXPERIENCED A FLASHING RED LIGHT ON THEIR DEVICE APPROXIMATELY (B)(6), 2017. ON (B)(6) 2017, THE SITE REPORTED THAT THEY COULD NOT RESTART THERAPY. THE CLINICIAN PROGRAMMER INDICATED ERROR CODE 25 (TOO MANY THERAPY RETRIES). IMPEDANCE TESTING INDICATED HIGH POSTERIOR TIP TO RING AND ANTERIOR TIP TO POSTERIOR TIP IMPEDANCE MEASUREMENTS.

  Patient problems: Failure of Implant

  MAUDE report 6814574 ↗
• MalfunctionAug 16, 2017High impedance; Device Inoperable; Therapeutic or Diagnostic Output Failure; High impedance; Device Inoperable; Therapeutic or Diagnostic Output Failure

  HIGH IMPEDANCE OF THE POSTERIOR LEAD WAS EXPERIENCED DURING AN INITIAL IMPLANT PROCEDURE OF THE MAESTRO RECHARGEABLE SYSTEM IN THIS PATIENT. THE POSTERIOR LEAD WAS REPLACED DURING THE SAME PROCEDURE RESULTING IN IMPEDANCE VALUES WITHIN THE ACCEPTABLE RANGE AND SUCCESSFUL ACTIVATION OF THERAPY. THE INITIAL POSTERIOR LEAD THAT RESULTED IN HIGH IMPEDANCE MEASUREMENTS WAS RETURNED FOR ANALYSIS. HIGH IMPEDANCE OF THE ANTERIOR LEAD WAS ALSO EXPERIENCED DURING THIS PROCEDURE. REFER TO MDR3005025697-2017-00017 FOR REPORT OF THE ANTERIOR LEAD.

  Patient problems: Failure of Implant

  MAUDE report 6798641 ↗
• MalfunctionMay 24, 2017Device Inoperable; Device Displays Incorrect Message; Material Distortion; Material Twisted/Bent; Device Inoperable; Device Displays Incorrect Message; Material Distortion; Material Twisted/Bent

  THIS SUBJECT IS A PARTICIPANT IN THE (B)(6) 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. IMPEDANCE ISSUES WERE REPORTED RELATED TO THE IMPLANTED ANTERIOR LEAD (REFERENCE MDR3005025697-2017-00001 FOR INFORMATION ON THAT COMPONENT). DURING A REVISION PROCEDURE TO REPLACE THE ANTERIOR LEAD, IT WAS DISCOVERED THAT THE ANTERIOR LEAD AND POSTERIOR LEAD WERE TWISTED AROUND EACH OTHER IN THE POCKET OF THE RECHARGEABLE NEUROREGULATOR. AS A RESULT, THE POSTERIOR LEAD WAS ALSO REPLACED. THE REVISION PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ADVERSE IMPACT TO THE SUBJECT. EXPLANTED DEVICE COMPONENTS HAVE NOT YET BEEN RECEIVED BY ENTEROMEDICS. REFERENCE MDR3005025697-2017-00001 FOR REPORT RELATED TO THE ANTERIOR LEAD.

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

  MAUDE report 6589490 ↗
• MalfunctionMay 24, 2017Electrical /Electronic Property Problem; Material Separation; Device Inoperable; Low impedance; Device Displays Incorrect Message; Material Distortion; Electrical /Electronic Property Problem; Material Separation; Device Inoperable; Low impedance; Device Displays Incorrect Message; Material Distortion

  A SUBJECT PARTICIPATING IN THE (B)(6) TRIAL (SUBJECT ID (B)(6)) UNDERWENT INITIAL IMPLANTATION OF THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2011. THIS SUBJECT HAS HAD A HISTORY OF MULTIPLE LOW IMPEDANCE EVENTS RELATED TO THE IMPLANTED POSTERIOR LEAD, RESULTING IN A NEED TO RESTART THERAPY. REPORTED LOW IMPEDANCE EVENTS FOR THIS SUBJECT OCCURRED ON (B)(6) 2014, (B)(6) 2015, (B)(6) 2016, AND A FINAL REPORT OF CONTINUED IMPEDANCE ISSUES ON (B)(6) 2016. ON (B)(6) 2016, IT WAS ALSO REPORTED THAT THIS SUBJECT IS UNRELIABLE WITH CHARGING AND ATTENDING CLINIC VISITS. ON APRIL 27, 2017, ENTEROMEDICS WAS INFORMED THAT THIS SUBJECT HAS DECIDED TO HAVE THE DEVICE EXPLANTED. THE DEVICE WAS SUBSEQUENTLY EXPLANTED WITHOUT INCIDENT ON (B)(6) 2017.

  Patient problems: Failure of Implant; Therapeutic Response, Decreased

  MAUDE report 6589485 ↗
• 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 (IDE (B)(4); (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 EMPOWER CLINICAL TRIAL ON (B)(6) 2008, WERE NOT REPLACED AT THE TIME OF THE 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 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 6370136 ↗
• 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 (B)(6) CLINICAL TRIAL (IDE G070025; SUBJECT (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 APRIL 14, 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 APRIL 21, 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 6370110 ↗
• MalfunctionJan 18, 2017Electrical /Electronic Property Problem; Fracture; Device Inoperable; Low impedance; Device Displays Incorrect Message; Electrical /Electronic Property Problem; Fracture; Device Inoperable; Low impedance; Device Displays Incorrect Message

  A SUBJECT PARTICIPATING IN THE RECHARGE CLINICAL TRIAL (SUBJECT ID (B)(6) UNDERWENT INITIAL IMPLANTATION OF THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2011. SUBJECT PRESENTED WITH RED LIGHT (B)(6) 2015. INTERROGATION WITH CLINICIAN PROGRAMMER INDICATED POSTERIOR TIP TO RING SHORT SINCE (B)(6) 2015 WITH DISPLAY OF ERROR MESSAGE. THERAPY WAS RESTARTED BY SITE. SAME ISSUE OCCURRED (B)(6) 2015 AND AGAIN ON (B)(6) 2015 WITH THERAPY RESTARTED AFTER EACH EVENT. MAESTRO RECHARGEABLE SYSTEM WAS EXPLANTED ON (B)(6) 2015. SUBJECT EXPERIENCED SEROMA FOLLOWING EXPLANT WHICH RESOLVED WITHOUT SURGICAL OR MEDICAL INTERVENTION.

  Patient problems: Failure of Implant; Therapeutic Response, Decreased

  MAUDE report 6262399 ↗
• MalfunctionOct 5, 2016Electrical /Electronic Property Problem; High impedance; Device Inoperable; Device Displays Incorrect Message; Electrical /Electronic Property Problem; High impedance; Device Inoperable; Device Displays Incorrect Message

  A SUBJECT PARTICIPATING IN THE RECHARGE CLINICAL TRIAL (SUBJECT ID (B)(4)) UNDERWENT INITIAL IMPLANTATION OF THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2011. ON (B)(6) 2015, THIS SUBJECT UNDERWENT REPLACEMENT OF THE ANTERIOR LEAD AND RECHARGEABLE NEUROREGULATOR, WITH NO REPLACEMENT OF THE POSTERIOR LEAD AT THAT TIME. ON (B)(6) 2016, THE SITE REPORTED THAT THE PATIENT HAD A FLASHING RED LIGHT DURING ATTEMPTED CHARGING. DURING A CLINIC VISIT ON (B)(6) 2016, AN ERROR MESSAGE (CODE 12: PULSE CURRENT BELOW MINIMUM THRESHOLD) WAS ENCOUNTERED. THIS CODE WAS CLEARED DURING THE VISIT. LATER IN THE DAY ON (B)(6) 2016, THE SUBJECT AGAIN REPORTED A FLASHING RED LIGHT. ON (B)(6) 2016, THE SUBJECT WAS AGAIN SEEN IN THE CLINIC. SEVERAL ERROR MESSAGES WERE ENCOUNTERED (CODE 12: PULSE CURRENT BELOW MINIMUM THRESHOLD, CODE 25: TOO MANY THERAPY RETRIES, AND CODE 3: HIGH IMPEDANCE). THIS SUBJECT IS NOT RECEIVING THERAPY FROM THE DEVICE.

  Patient problems: Failure of Implant; Therapeutic Response, Decreased

  MAUDE report 6000074 ↗
• MalfunctionOct 5, 2016Bent; Electrical /Electronic Property Problem; Material Separation; Device Inoperable; Low impedance; Device Displays Incorrect Message; Material Deformation; Bent; Electrical /Electronic Property Problem; Material Separation; Device Inoperable; Low impedance; Device Displays Incorrect Message; Material Deformation

  (B)(6) SUBJECT PARTICIPATING IN THE (B)(6) CLINICAL TRIAL (SUBJECT ID (B)(6)), WAS ORIGINALLY IMPLANTED WITH A SHAM CONTROL DEVICE (SHAM NEUROREGULATOR) ON (B)(6) 2011. THIS SUBJECT SUBSEQUENTLY UNDERWENT CONVERSION TO THE ACTIVE MAESTRO RECHARGEABLE SYSTEM, WITH AN ACTIVE RECHARGEABLE NEUROREGULATOR, ANTERIOR LEAD AND POSTERIOR LEAD IMPLANTED ON (B)(6) 2013. ON (B)(6) 2016, LOW IMPEDANCE OF THE POSTERIOR LEAD WAS DETECTED DURING A CLINIC VISIT. THE ASSOCIATED ALERTS WERE CLEARED DURING THE VISIT, BUT RECURRED WITHIN 24 HOURS. AS A RESULT, THIS SUBJECT IS NOT RECEIVING THERAPY FROM THE DEVICE.

  Patient problems: Failure of Implant; Therapeutic Response, Decreased

  MAUDE report 6000063 ↗
• 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 PERSISTANT LOW IMPEDANCE OF THE POSTERIOR LEAD. A REVIEW OF THE LOG DATA INDICATED SHORTS ON (B)(6) 2015. AS A RESULT, IT WAS DETERMINED THAT AN EXPLANT AND REVISION PROCEDURE WERE REQUIRED.

  Patient problems: Failure of Implant

  MAUDE report 5683374 ↗
• InjuryMay 19, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  A SUBJECT PARTICIPATING IN THE (B)(6) CLINICAL TRIAL WAS UNDERGOING PLANNED CONVERSION TO THE COMMERCIAL MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 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)(6) 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

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

  MAUDE report 5667963 ↗
• MalfunctionOct 27, 2015Electrical /Electronic Property Problem; Fracture; Device Inoperable; Low impedance; Device Displays Incorrect Message

  SUBJECT PARTICIPATING IN THE RECHARGE CLINICAL TRIAL ((B)(4)) EXPERIENCED LOW IMPEDANCE OF POSTERIOR LEAD. SUBJECT REPORTED RED LIGHT ON EXTERNAL MOBILE CHARGER DURING A CLINIC VISIT ON (B)(6), 2015. INTERROGATION OF THE DEVICE INDICATED ERROR CODES INCLUDING LOW RNR AND POSTERIOR TIP TO RING SHORT. ERROR CODES WERE CLEARED, AND THERAPY WAS DELIVERED UNTIL (B)(6), 2015. THE SUBJECT WAS UNABLE TO CHARGE WITH THE MOBILE CHARGER, SO THE MOBILE CHARGER WAS REPLACED; TEMPORARILY RESOLVING THE LOW RNR BATTERY ISSUE. THE IMPORTANCE OF REGULAR CHARGING WAS EMPHASIZED TO THE SUBJECT. ON (B)(6), 2015, POSTERIOR TIP TO RING SHORTS WERE REPORTED. REVIEW OF LOG DATA INDICATE SHORTS ON (B)(6), 2015. ON SEPTEMBER 29, 2015, IT WAS DETERMINED THE LOW IMPEDANCE STATE WOULD PERSIST AND PREVENT THERAPY DELIVERY, AND THE NEED FOR SURGICAL REVISION WAS INITIALLY RECOMMENDED. THEREFORE, THIS EVENT WAS THEN DETERMINED, ON (B)(6), 2015, TO BE A REPORTABLE EVENT. A FOLLOW-UP REPORT WILL BE FILED AFTER COMPLETION OF THE REVISION/EXPLANT PROCEDURE, IF COMPLETED, AND INVESTIGATION OF RETURNED COMPONENTS, IF AVAILABLE.

  Patient problems: Failure of Implant; Therapeutic Response, Decreased

  MAUDE report 5181543 ↗
• MalfunctionSep 25, 2015Device Inoperable; Low impedance; Low Readings

  DURING DEVICE IMPLANTATION, INITIAL IMPLANT IMPEDANCE MEASUREMENTS WERE ACCEPTABLE. DURING THE FINAL PLACEMENT OF THE NEUROREGULATOR, A LOW IMPEDANCE ALARM WAS INDICATED ON THE POSTERIOR LEAD. THE LOW IMPEDANCE ALARM, IN ACCORDANCE WITH INTENDED PRODUCT DESIGN, PREVENTED INITIATION OF THERAPY. BECAUSE THE PROCEDURE HAD BEEN COMPLETED TO THE POINT WHERE MEDICAL ADHESIVE COVERED THE LEAD CONNECTION ON THE NEUROREGULATOR, BOTH THE NEUROREGULATOR AND POSTERIOR LEAD WERE REMOVED AND REPLACED WITH ALTERNATE COMPONENTS IN ACCORDANCE WITH STANDARD PRACTICE. IMPLANTATION OF ALTERNATE COMPONENTS RESOLVED THE LOW IMPEDANCE ALARMS. THE IMPLANTATION PROCEDURE COMPLETED SUCCESSFULLY WITHOUT ADVERSE IMPACT TO THE PATIENT. FINAL IMPEDANCE MEASUREMENTS WERE SOMEWHAT LOW, SO THE IMPEDANCE AMPLITUDE SETTING WAS NOT LOWERED AS TYPICALLY DONE AT IMPLANT, TO ENSURE BETTER IMPEDANCE MEASUREMENT ACCURACY.

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

  MAUDE report 5104219 ↗