Nalu Medical, Inc. 71019-US (UDI 00812537035604)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00812537035604), received between Mar 14, 2022 and Sep 28, 2026 — classified as 44 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (15 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 3, 2024Class IIOpen, Classified

   Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.

   Z-2257-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920788 ↗
• MalfunctionSep 25, 2026Migration

  Patient problems: Headache; Inadequate Pain Relief

  MAUDE report 50899603 ↗
• MalfunctionSep 18, 2026Unexpected Therapeutic Results

  Patient problems: Inadequate Pain Relief

  MAUDE report 50828621 ↗
• InjuryMay 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 AFTER HAVING COMPLETED A SUCCESSFUL TRIAL AND WEAR STUDY WITH NALU. ON (B)(6) 2022 THE PATIENT REPORTED CONNECTIVITY ISSUES BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISC. XRAY IMAGING FOUND THAT THE IPG HAD MIGRATED WITHIN THE POCKET, CAUSING THE COMMUNICATION ISSUES. ADDITIONALLY, ONE OF THE IMPLANTED LEADS WAS FOUND TO HAVE MIGRATED OUT OF POSITION. THE DECISION WAS MADE TO REMOVE THE SYSTEM AND IMPLANT A NEW ONE IN A SLIGHTLY DIFFERENT LOCATION IN ORDER TO PROVIDE A MORE OPTIMAL CONNECTION BASED ON THE PATIENT'S SKIN AND FAT ANATOMY. THE REVISION PROCEDURE TOOK PLACE ON (B)(6) 2022. SEE MDR 3015425075-2022-00042. DURING A FOLLOW UP VISIT WITH THE PHYSICIAN ON (B)(6) 2022 IT WAS NOTED THAT THE PATIENT HAD INCISIONAL DEHISCENCE, EXPOSING THE LEAD WIRE. POCKET REVISION AND WOUND CLOSURE WAS PERFORMED ON (B)(6) 2022 AND THE PATIENT RESUMED PAIN RELIEF THERAPY. SEE MDR 3015425075-2022-00058. NO FURTHER COMPLAINTS OR ISSUES ARE DOCUMENTED FOR THIS PATIENT AFTER THE WOUND CLOSURE IN (B)(6) 2022 UNTIL THE FIRM WAS NOTIFIED IN (B)(6) 2025 THAT THE PATIENT IS NO LONGER USI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21982146 ↗
• InjuryMar 21, 2025Inadequate User Interface; Inadequate User Interface

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2021 TO TREAT LOWER BACK PAIN. THE SYSTEM WAS ACTIVATED AND IN USE, HOWEVER IN 2023 THE PATIENT STOPPED SEEING THE PHYSICIAN THAT HAD IMPLANTED THE NALU DEVICE AND CEASED COMMUNICATION WITH ANYONE FROM THE NALU FIRM. IN AUGUST 2024 THE FIRM WAS NOTIFIED THAT THE PATIENT WAS REQUESTING AN EXPLANT. THE EXPLANT PROCEDURE WAS SCHEDULED, BUT THEN CANCELLED FOR AN UNKNOWN REASON. THE PATIENT'S NEW PHYSICIAN STATED THE PATIENT HAD STOPPED USING THE NALU SYSTEM AND THE PHYSICIAN REQUESTED FOR THE PATIENT TO MEET WITH A NALU REPRESENTATIVE AND TRY USING THE SYSTEM AGAIN. WHEN SCHEDULING THE REPROGRAMMING, THE NALU REPRESENTATIVE DISCOVERED THAT THE PATIENT WOULD REQUIRE NEW THERAPY DISCS. APPARENTLY, THE PATIENT HAD BECOME FRUSTRATED THE PRIOR YEAR WITH THE SYSTEM DUE TO THE ADHESIVE CLIPS, BUT DID NOT INFORM THE LOCAL REP OF THE ISSUE. PATIENT STOPPED USING THE SYSTEM AND DISCARDED THE THERAPY DISCS DUE TO THAT FRUSTRATION. PATIENT WAS ISSUED NEW THERAPY DISCS AND REPROGRAMMING WAS COMPLETED IN (B)(6) 2024. THE SYSTEM APPEARED TO BE FUNCTIONING WELL BUT THE PATIENT REPORTED FRUSTRATION WITH USING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21669750 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022. AFTER USING THE SYSTEM FOR SEVERAL YEARS, THE PATIENT HAS HAD A DECLINE IN MENTAL STATUS AND IS STRUGGLING TO USE THE SYSTEM. THE PATIENT'S DAUGHTER AND PHYSICIAN AGREE THAT THE SYSTEM SHOULD BE REMOVED. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025 PER THE REQUEST OF THE PATIENT AND FAMILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21669748 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT LOWER BACK PAIN AND INITIALLY REPORTED 70% PAIN RELIEF WITH THE NALU SYSTEM. IN (B)(6) 2024 THE PATIENT REPORTED THAT THE NALU SYSTEM WAS NO LONGER PROVIDING ADEQUATE PAIN RELIEF. ADDITIONALLY, THE PATIENT REPORTEDLY WILL REQUIRE MULTIPLE MEDICAL SCANS DUE UNDERLYING MEDICAL CONDITIONS. SPECIFICS AROUND THE PATIENT'S DIAGNOSIS IS UNKNOWN, ONSET DATE WAS ALSO NOT SHARED WITH NALU PERSONNEL. ON (B)(6) 2024 THE NALU SYSTEM WAS EXPLANTED PER PATIENT REQUEST. ALL COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY AT THE TIME OF EXPLANT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21136642 ↗
• InjuryOct 31, 2024Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2021 AND REPORTED IMPROVEMENT IN PAIN SYMPTOMS. IN (B)(6) 2024 THE PATIENT NOTED SOME ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS, RESULTING IN INADEQUATE PAIN RELIEF FOR THE PATIENT. IMAGING FOUND THAT THE IPG HAD MIGRATED WITHIN THE POCKET AND WAS NO LONGER IN THE APPROPRIATE POSITION TO ACHIEVE OPTIMAL COMMUNICATION. PATIENT REQUESTED TO REMOVE THE SYSTEM. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024 PER PATIENT REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20578886 ↗
• InjurySep 5, 2024Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT LOWER BACK AND HIP PAIN. ON (B)(6) 2024 A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO PATIENT NEED FOR MRI SCAN. THE FIRM WAS NOT NOTIFIED OF THE PLANNED EXPLANT PRIOR TO THE PROCEDURE AND THUS NO NALU PERSONNEL WERE PRESENT AND THE DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154069 ↗
• InjuryAug 20, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 TO REPLACE AN EXISTING SYSTEM FROM A DIFFERENT MANUFACTURER. ON (B)(6) 2024 THE FIRM WAS NOTIFIED BY THE IMPLANTING PHYSICIAN THAT THE PATIENT HAD EXPERIENCED LEAD MIGRATION AND WOULD REQUIRE A SURGICAL PROCEDURE TO REPOSITION THE LEADS. ON (B)(6) 2024 THE SURGICAL PROCEDURE WAS PERFORMED. THE PHYSICIAN ELECTED TO FULLY REMOVE THE SINGLE 8-CONTACT LEAD AND REPLACE WITH TWO 4-CONTACT LEADS. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ALSO REPLACED DURING THE PROCEDURE OUT OF CAUTION DUE TO HANDLING OF THE DEVICE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20007287 ↗
• InjuryJun 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2021, TARGETING THE AXILLARY AND SUPRASCAPULAR NERVES. IN (B)(6) 2024 THE PATIENT REQUESTED TO HAVE THE SYSTEM EXPLANTED. A LOCAL NALU REPRESENTATIVE FOUND THAT THE PATIENT WAS UNABLE TO VERBALIZE ANY SPECIFIC ISSUE AND EXPRESSED GENERALIZED FRUSTRATION. PATIENT REPORTED NOT RECEIVING ADEQUATE PAIN RELIEF AND DECLINED ANY TROUBLESHOOTING OR REPROGRAMMING OFFERS. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024 PER THE PATIENT REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19613908 ↗
• InjuryJun 6, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT KNEE PAIN. IN (B)(6) 2024 PATIENT REPORTED LOSS OF THERAPY. FLUOROSCOPY IMAGING CONFIRMED LEAD MIGRATION. PATIENT WAS OFFERED REVISION PROCEDURE TO PLACE THE LEADS BACK IN THE DESIRED LOCATION. PATIENT REFUSED REVISION AND REQUESTED TO HAVE THE SYSTEM REMOVED. ON (B)(6)2024 A FULL SYSTEM EXPLANT WAS PERFORMED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19480707 ↗
• InjuryMay 24, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT LOWER BACK PAIN. IN (B)(6) 2024, APROXIMATELY 2 YEARS AFTER THE INITIAL IMPLANT, THE PATIENT REPORTED THAT THE SYSTEM WAS NO LONGER PROVIDING ADEQUATE RELIEF. INVESTIGATION, INCLUDING FLOUROSCOPY IMAGING, FOUND THAT THE MEDIAL LEAD HAD SLIGHTLY MIGRATED, LIKELY CAUSING THE LOSS OF PAIN RELEIF. A REPROGRAMMING WAS PERFORMED TO ATTEMPT TO IMPROVE PAIN RELIEF WITHOUT INVASIVE MEASURES, HOWEVER THE PATIENT REPORTED PERSISTENCE OF INADEQUATE PAIN RELIEF. ON (B)(6) 2024 A SURGICAL REVISION WAS PERFORMED TO PLACE A NEW LEAD BACK AT THE DESIRED NERVE TARGET.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19397747 ↗
• InjuryApr 2, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE SYSTEM ON (B)(6) 2022 AND REPORTED RECEIVING PAIN RELIEF FROM THE SYSTEM. IN (B)(6) 2023, APPROXIMATELY ONE YEAR AFTER BEING IMPLANTED, THE PATIENT REPORTED NOT GETTING RELIEF FROM THE SYSTEM AFTER SUSTAINING A FALL IN JANUARY 2023. TROUBLESHOOTING WAS PERFORMED, INCLUDING REPROGRAMMING, WITHOUT SUCCESS. XRAY IMAGING FOUND THE MEDIAL LEAD HAD MIGRATED. PATIENT DECLINED TO HAVE THE LEAD REPOSITIONED AND A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024 PER THE PATIENT'S REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19020754 ↗
• InjuryJan 27, 2024Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2021 TO TREAT LOWER BACK PAIN. IN (B)(6) 2023 THE PATIENT INDICATED A DESIRE TO REMOVE THE SYSTEM DUE TO INADEQUATE PAIN RELIEF. PATIENT WAS OFFERED REPROGRAMMING AND TROUBLESHOOTING TO IMPROVE SATISFACTION WITH THE SYSTEM, PATIENT REFUSED. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2023 PER THE PATIENT REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18592777 ↗
• InjuryJan 20, 2024Fracture; Fracture

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2021. IN (B)(6) 2023 THE PATIENT REPORTED LOSS OF THERAPY AND XRAY IMAGING SHOWED A FRACTURE OF THE IMPLANTED LEAD. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2023 TO REPLACE THE FRACTURED LEAD. DURING THE PROCEDURE THE PHYSICIAN CHOSE TO ALSO REPLACE THE IMPLANTABLE PULSE GENERATOR (IPG) ALTHOUGH THERE WERE NO INDICATIONS OF ANY ISSUE WITH THAT COMPONENT PRIOR TO THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18548893 ↗
• InjuryJan 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023. AFTER BEING IMPLANTED THE PATIENT REPORTED DISCOMFORT AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2023 TO MOVE THE IPG TO AN AREA WITH MORE TISSUE TO SUPPORT THE IMPLANT.

  Patient problems: Discomfort

  MAUDE report 18461546 ↗
• InjuryNov 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM ON (B)(6) 2022 TARGETING THE SUPRASCAPULAR NERVE TO TREAT SHOULDER PAIN. ON (B)(6) 2023 THE FIRM WAS NOTIFIED BY THE SURGICAL CENTER THAT THE PATIENT WAS SCHEDULED FOR A FULL SYSTEM EXPLANT. PATIENT EXPRESSED THAT THEY DID NOT FEEL LIKE ADEQUATE PAIN RELIEF WAS BEING ACHIEVED, PATIENT WANTS TO EXPLANT THE PNS SYSTEM AND PURSUE A SPINAL CORD STIMULATOR SYSTEM. NO FURTHER INFORMATION WAS SHARED WITH THE FIRM. A FULL SYSTEM EXPLANT TOOK PLACE ON (B)(6) 2023.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18243746 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT KNEE PAIN. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2023 IN PREPARATION FOR A KNEE REPLACEMENT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18235217 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2023, REPLACING AN EXISTING COMPETITOR SYSTEM. WHEN PATIENT WAS SEEN IN THE CLINIC FOR ACTIVATION ON (B)(6)2023 THERE WAS NO CONCERNS AND THE ACTIVATION WENT WELL. PATIENT REPORTED RECEIVING GOOD PAIN RELIEF FROM THE NALU SYSTEM, HOWEVER THE INCISION SITE DEVELOPED AN INFECTION AND DID NOT RESPOND AS EXPECTED TO ANTIBIOTIC TREATMENT. THE FULL NALU SYSTEM WAS EXPLANTED ON (B)(6)2023 DUE TO THE INFECTION OF THE SURGICAL INCISION AND FAILURE TO PROPERLY HEAL.

  Patient problems: Post Operative Wound Infection

  MAUDE report 17917436 ↗
• InjuryOct 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023. AFTER THE IMPLANT PROCEDURE WAS PERFORMED, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR UNKNOWN REASONS AND WAS HOSPITALIZED DUE TO POST-OPERATIVE PAIN UNRELATED TO THE NALU SYSTEM. DURING THE HOSPITALIZATION THE PATIENT TESTED POSITIVE FOR STAPH INFECTION FROM AN UNKNOWN SOURCE AND UNKNOWN ORIGINATION SITE AND THE DECISION WAS MADE TO REMOVE THE NALU SYSTEM AT THAT TIME. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17892708 ↗
• InjuryOct 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 AND REPORTED RECEIVING SOME PAIN RELIEF BUT WAS NOT SATISFIED WITH THE LEVEL OF RELIEF BEING ACHIEVED. REPROGRAMMING WAS PERFORMED IN (B)(6) 2022 TO ATTEMPT TO ACHIEVE A HIGHER LEVEL OF RELIEF FOR THE PATIENT. AFTER THE REPROGRAMMING, THE PATIENT BECAME UNRESPONSIVE. ON (B)(6) 2023 A NALU REPRESENTATIVE RECEIVED NOTIFICATION THAT THE PATIENT REPORTED TO THE PHYSICIAN THAT THEY WERE DISSATISFIED WITH THE LEVEL OF THERAPY BEING RECEIVED AND DID NOT WISH TO PERFORM ANY TROUBLESHOOTING OR REPROGRAMMING. PATIENT REQUESTED EXPLANT. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17884852 ↗
• InjuryAug 2, 2023Migration; Migration

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022. AFTER ACTIVATION THE PATIENT REPORTED LOSS OF PAIN RELIEF AND XRAY IMAGING CONFIRMED THE IMPLANTED LEADS HAD MIGRATED AWAY FROM THE TARGET NERVES. ON (B)(6) 2022 A SURGICAL REVISION WAS PERFORMED TO REPLACE THE IMPLANTED LEADS AND POSITION THE NEW LEADS AT THE TARGET NERVE TO PROVIDE PAIN RELIEF THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17447330 ↗
• InjuryAug 2, 2023Migration; Migration

  "PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 AND LATER REPORTED THAT THE AREA OF STIMULATION WAS NOT THE AREA OF PAIN. XRAY IMAGING FOUND THE IMPLANTED LEADS HAD MIGRATED AWAY FROM THE TARGET NERVE. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2022 TO REPLACE THE EXISTING LEADS AND POSITION THE REPLACEMENT LEADS AT THE TARGET NERVE FOR PAIN RELIEF THERAPY."

  Patient problems: Inadequate Pain Relief

  MAUDE report 17446507 ↗
• InjuryAug 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2021 TO REPLACE AN EXISTING THIRD PARTY SYSTEM. AT THE TIME OF THE ORIGINAL IMPLANT, THE PATIENT WAS ISSUED TWO TINED LEAD KITS AS WELL AS THE IMPLANTABLE PULSE GENERATOR. AN ADDITIONAL TINED LEAD KIT WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022 A SURGICAL REVISION PROCEDURE WAS PERFORMED IN WHICH THE PATIENT WAS ISSUED A REPLACEMENT IMPLANTABLE PULSE GENERATOR AND LEAD KIT, AS WELL AS CONNECTOR CABLE AND EXTENSION.

  Patient problems: Insufficient Information

  MAUDE report 17446352 ↗