Nalu Medical, Inc. 71019-US (UDI 00812537036441)Recalls & reported problems

Summary

The FDA's MAUDE database contains 225 adverse event reports that list this exact device (DI 00812537036441), received between Aug 17, 2022 and Sep 30, 2026 — classified as 220 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Migration” (56 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 225 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Break

  Patient problems: Wound Dehiscence

  MAUDE report 50946534 ↗
• InjurySep 29, 2026High impedance

  Patient problems: Inadequate Pain Relief

  MAUDE report 50938819 ↗
• MalfunctionSep 29, 2026High impedance

  Patient problems: Inadequate Pain Relief

  MAUDE report 50936327 ↗
• MalfunctionSep 23, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872132 ↗
• MalfunctionSep 22, 2026Migration

  Patient problems: Discomfort

  MAUDE report 50862702 ↗
• MalfunctionSep 22, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859444 ↗
• InjurySep 22, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858874 ↗
• MalfunctionSep 21, 2026Material Frayed

  The Nalu Sales Representative (rep) reported that a defective Implantable Pulse Generator (IPG) was discovered during perm implant. After the leads were placed and tested, impedance and paresthesia mapping were good. Moved on to tunnel the leads. After leads were tunneled, moved on to hooking up the IPG and leads. Impedance check did not clear on contact B4. Physician wanted to give IPG a depth test with therapy disc to see if there were any other issues with the IPG. During the pocketing procedure physician noticed what looked like a piece of wire protruding from the tail of the IPG. Upon closer inspection, there was in fact wire hanging out of the tail. The physician and Nalu rep both agreed that this IPG should not be utilized due to the bad impedance reading on contact B4 and the wire protruding from the tail of the IPG. A new IPG was used to complete the case. There was no reported patient harm or injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840744 ↗
• InjurySep 13, 2026Insufficient Device Problem Information

  Patient problems: Implant Pain

  MAUDE report 50746896 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50744646 ↗
• InjuryMar 30, 2026Migration

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT ABDOMINAL PAIN. AFTER IMPLANT, THE PATIENT COMPLAINED OF LOCALIZED PAIN OR DISCOMFORT WHICH THE PHYSICIAN BELIEVED WAS RELATED TO THE PLACEMENT OF THE IMPLANTED ANCHORS IN CONJUNCTION WITH THE PATIENT'S LOW BODY MASS. ON (B)(6) 2023 A PROCEDURE WAS PERFORMED TO MOVE THE EXISTING IMPLANTED LEADS AND ANCHORS TO A LESS SUPERFICIAL POSITION TO ALLEVIATE THE PATIENT DISCOMFORT. NO COMPONENTS WERE EXPLANTED OR REPLACED DURING THE PROCEDURE. SEE MDR 3015425075-2023-00302. THE PATIENT UTILIZED THE SYSTEM FOR APPROXIMATELY 2 YEARS BEFORE AGAIN REPORTING MILD TO MODERATE PAIN NEAR THE LEAD SITE. THE PHYSICIAN ASSESSED THE PATIENT AND SYSTEM AND DETERMINED THAT THE LEADS MAY HAVE MIGRATED DISTALLY, CAUSING THE DISCOMFORT. ON (B)(6) 2025 A PROCEDURE WAS PERFORMED TO LOOSEN THE ANCHORS AND REPOSITION THE EXISTING LEADS, THEN RE-ANCHOR. NO COMPONENTS WERE REMOVED OR REPLACED DURING THE PROCEDURE.

  Patient problems: Implant Pain

  MAUDE report 24737548 ↗
• InjuryMar 11, 2026Improper or Incorrect Procedure or Method

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023. AFTER HEALING FROM THE PROCEDURE, IT WAS NOTED THAT THE IMPLANTED LEAD WAS VERY SUPERFICIAL UNDER THE SKIN. ON (B)(6) 2024 A SURGICAL INTERVENTION WAS PERFORMED TO REPOSITION THE LEAD. NO COMPONENTS WERE REMOVED OR REPLACED DURING THE PROCEDURE. SEE MDR 3015425075-2024-00121. SURGICAL INTERVENTION WAS PERFORMED TO REPOSITION THE IMPLANTED LEAD ONLY, THERE ARE NO ISSUES WITH ANY PORTION OF THE NALU SYSTEM OR ITS COMPONENTS FAILING OR MALFUNCTIONING. DURING THE SUBSEQUENT 2 YEARS, THE PATIENT RELOCATED RESIDENCE TO A NEW AREA AND WAS REFERRED TO A DIFFERENT PHYSICIAN TO ASSESS LACK OF STIMULATION AT THE LEFT LEAD. TESTING OF THE SYSTEM FOUND THAT THE PLACEMENT OF THE LEFT LEAD WAS INAPPROPRIATE FOR ACHIEVING PARESTHESIA AND WAS NOT PROVIDING THERAPY TO THE PATIENT'S PAIN LOCATION. ON (B)(6) 2026 A SECOND SURGICAL REVISION WAS PERFORMED TO REMOVE THE MALPOSITIONED LEFT LEAD AND PLACE A NEW LEAD AT A LOCATION TO PROVIDE THERAPY FOR THE PATIENT. PRIOR TO CLOSING THE CASE, THE LEAD WAS CONFIRMED TO ACHIEVE PARESTHESIA AND BOTH LEADS WERE TESTED FOR IMPEDANCES, CONFIRMING THE SYSTEM WAS FUNCTIONING AS EXP

  Patient problems: Inadequate Pain Relief

  MAUDE report 24575605 ↗
• InjuryMar 11, 2026Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHER NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT SHOULDER PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE BADGE AREA ON THE BACK OF THE ARM WITH THE LEADS TARGETING THE AXILLARY AND SUPRASCAPULAR NERVES. AFTER THE IMPLANT, THE IPG MIGRATED TOWARD THE PATIENT'S ARMPIT AREA, MAKING IT CHALLENGING FOR THE PATIENT TO ACCESS AND PLACE THE EXTERNAL ADHESIVE CLIPS. THE PATIENT REPORTED GOOD THERAPY AND WAS ABLE TO ACHIEVE CONNECTION BETWEEN THE IPG AND THERAPY DISCS, HOWEVER THE LOCATION OF THE IPG AFTER MIGRATION MADE IT CHALLENGING FOR THE PATIENT TO USE THE SYSTEM. WHILE ASSESSING THE SYSTEM IT WAS ALSO DETERMINED THAT THE AXILLARY NERVE HAD MIGRATED SLIGHTLY, ALTHOUGH STILL PROVIDING STIMULATION. ADDITIONALLY, THE PATIENT REPORTED NOT HAVING ANY PAIN SYMPTOMS IN THE UPPER ARM AND THUS THE AXILLARY LEAD PLACEMENT WAS NOT NEEDED. ON (B)(6) 2026 A SURGICAL REVISION WAS PERFORMED TO MOVE THE IPG TO A HIGH TRAPEZIUS LOCATION FOR EASIER ACCESSIBILITY FOR THE PATIENT. DURING THE PROCEDURE, BOTH ORIGINAL LEADS WERE REMOVED, AND 2 NEW LEADS WERE IMPLANTED TARGETING THE RIGHT SUPRASCAPULAR NERVE ONLY TO ADDRESS THE PATIENT'S PRIMARY PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570093 ↗
• InjuryFeb 19, 2026Improper or Incorrect Procedure or Method

  THE PATIENT HAD BEEN IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM IN (B)(6) IN (B)(6) 2024 TO TREAT BACK PAIN. IN (B)(6) 2026 THE FIRM WAS NOTIFIED THAT THE NALU SYSTEM WAS SCHEDULED FOR EXPLANT IN (B)(6) IN PREPARATION FOR MRI. THE EXPLANTING PHYSICIAN NOTED INEFFECTIVE THERAPY AS WELL AS MRI CONDITIONALITY AS THE REASON FOR EXPLANT. THE SYSTEM WAS REMOVED ON (B)(6) 2026.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24393124 ↗
• InjuryJan 20, 2026Impedance Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. ON (B)(6) 2024 A SURGICAL REVISION WAS PERFORMED TO REPLACE THE IMPLANTABLE PULSE GENERATOR (IPG) AFTER IT MIGRATED AWAY FROM THE ORIGINAL IMPLANT LOCATION (SEE MDR 3015425075-2024-00280). THE SYSTEM WAS THEN IN USE FOR MORE THAN A YEAR WHEN IMPEDANCE ISSUES WERE DISCOVERED. ON (B)(6) 2025 A SECOND SURGICAL REVISION WAS PERFORMED TO REMOVE ALL IMPLANTED COMPONENTS AND PLACE A NEW IPG AND LEADS SO THAT THE PATIENT COULD MOVE FORWARD WITH A PLANNED MRI SCAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24114355 ↗
• InjuryDec 1, 2025Impedance Problem; Impedance Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT KNEE PAIN. IN (B)(6) 2025 THE PATIENT WAS AT AN ACUTE HOSPITAL FOR SEVERE HEADACHES, NECK STIFFNESS, AND PERIPHERAL VISION LOSS THAT IS UNRELATED TO THE AREA BEING TREATED BY THE NALU DEVICE. PRIOR TO BEING DISCHARGED FROM THE HOSPTIAL THE PATIENT WAS ORDERED TO HAVE AN MRI. PRE-MRI CHECK OF THE NALU SYSTEM FOUND IMPEDANCE ERRORS ON 5 CONTACTS AND THE MRI WAS NOT ABLE TO BE COMPLETED. REVIEW OF RECORDS FOUND IMPEDANCE ISSUES DATING BACK TO 2023, HOWEVER THERE IS NO RECORD OF ANY COMPLAINTS AROUND EFFICACY OF THE NALU SYSTEM AND THE PATIENT REPORTS THAT THE PAIN SYMPTOMS NALU WAS INTENDED TO TREAT WERE NO LONGER PRESENT AND THUS THE SYSTEM WAS NOT BEING USED. AT THE TIME OF THE HOSPITAL ADMISSION THE PATIENT WAS UNABLE TO COMPLETE THE ORDERED MRI DUE TO THE IMPEDANCE ISSUES WITH THE NALU SYSTEM. THE PATIENT WAS ULTIMATELY DISCHARGED HOME AND PLANNED TO REMOVE THE NALU SYSTEM. THE PATIENT CEASED COMMUNICATION WITH THE NALU TEAM AND THE FIRM WAS NOT CONSULTED FOR ANY PLANNED EXPLANT PROCEDURES. ON (B)(6) 2025 A REPRESENTATIVE OF THE FIRM REACHED OUT TO THE PHYSICIAN TO DETERMINE PATIENT ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687726 ↗
• InjuryDec 1, 2025Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. AFTER IMPLANTING THE SYSTEM AND USING IT FOR NEARLY A FULL YEAR, THE IMPLANTED LEADS MIGRATED AWAY FROM THE INITIAL LOCATION AT THE CLUNEAL NERVE AND THE PATIENT ELECTED TO REMOVE THE SYSTEM RATHER THAN REPOSITION THE LEADS. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025 PER THE PATIENT'S REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23687724 ↗
• InjuryNov 16, 2025Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT LOWER BACK PAIN. THE SYSTEM WAS IN USE FOR MORE THAN 18 MONTHS WHEN THE PATIENT REPORTED IN (B)(6) 2025 THAT THEY WERE EXPERIENCING ISSUES WITH CONNECTIVITY BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. TROUBLESHOOTING AND INVESTIGATION IN THE FIELD DETERMINED THAT THE IPG WAS MIGRATING WITHIN THE POCKET AS WELL AS THE PATIENT'S LOOSE SKIN ALLOWING THE EXTERNAL COMPONENTS TO SHIFT. ON (B)(6) 2025 A SURGICAL PROCEDURE WAS PERFORMED TO MOVE THE EXISTING IPG TO A MORE STABLE LOCATION APPROXIMATELY 1 INCH ABOVE THE ORIGINAL LOCATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23565868 ↗
• InjuryOct 15, 2025Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT LOWER BACK PAIN. AFTER USING THE SYSTEM FOR AN UNSPECIFIED TIME FRAME, THE PATIENT REPORTED REDUCTION IN THERAPY. THE PATIENT REPORTED THAT THE SYSTEM HAD INITIALLY ADDRESSED THE AREAS OF PAIN BUT THEN LATER STIMULATION WAS NO LONGER FELT IN THOSE SAME AREAS. IMAGING WAS PERFORMED AND CONFIRMED THE IMPLANTED LEADS HAD MIGRATED. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE MIGRATED LEADS AND PLACE NEW LEADS BACK AT THE DESIRED NERVE TARGET TO ADDRESS THE PATIENT'S PAIN LOCATION. THE ORIGINAL IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IMPLANTED AND IN USE WITH THE NEW LEADS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23306095 ↗
• InjurySep 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT HIP PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA WITH THE IMPLANTED LEADS TARGETING THE CLUNEAL NERVE. THE PATIENT WAS SEEN SEVERAL TIMES OVER THE SUBSEQUENT YEAR FOR REGULAR FOLLOW-UPS WITH NO REPORTS OF ANY ISSUES WITH THE NALU SYSTEM. IN (B)(6) 2025 A NALU REPRESENTATIVE WAS NOTIFIED BY THE MEDICAL CLINIC THAT THE PATIENT HAD REPORTED DEVELOPMENT OF A RASH ON THE SKIN OVER THE DISTAL END OF THE IMPLANTED LEADS. THE PATIENT WAS ADVISED TO STOP USING THE SYSTEM TO SEE IF THE SYMPTOMS WOULD RESOLVE. THE SYMPTOMS REMAINED EVEN WITH THE SYSTEM NOT IN USE AND ON (B)(6) 2025 A FULL SYSTEM EXPLANT WAS PERFORMED.

  Patient problems: Rash

  MAUDE report 23048216 ↗
• InjuryAug 23, 2025Impedance Problem; Impedance Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT KNEE PAIN. ON (B)(6) 2025, DURING A REGULAR FOLLOW-UP VISIT, THE SYSTEM WAS NOTED TO HAVE HIGH IMPEDANCE READINGS ON 2 CONTACTS OF ONE OF THE IMPLANTED LEADS. IN (B)(6) 2025 THE PATIENT REPORTED REDUCTION IN THERAPY FROM THE SYSTEM. IN (B)(6) 2025 THE PATIENT SUSTAINED A FALL BUT REPORTS NO DIRECT STRIKE AT THE IMPLANT LOCATION. DURING A PRE-MRI SYSTEM CHECK ON (B)(6) 2025 THE SYSTEM WAS AGAIN CONFIRMED TO HAVE IMPEDANCE ISSUES. THE PATIENT IS SCHEDULED FOR AN MRI TOWARD THE END OF 2025 AND REQUESTED A SYSTEM REVISION SO THAT THE MRI CAN TAKE PLACE. ON (B)(6) 2025 A FULL SYSTEM REPLACEMENT WAS PERFORMED TO PLACE A NEW IMPLANTABLE PULSE GENERATOR (IPG) AND NEW LEADS. ALL EXPLANTED COMPONENTS WERE DISCARDED DURING THE PROCEDURE AND THUS NOT AVAILABLE FOR FURTHER TESTING BY THE FIRM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22881253 ↗
• InjuryAug 10, 2025Migration; Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT LOWER BACK PAIN. IN (B)(6) 2025 AN MRI FACILITY REACHED OUT TO NALU TO DETERMINE THE PATIENT'S CONDITIONALITY. PATIENT WAS CONFIRMED TO BE CONDITIONAL BUT THE FACILITY WAS ADVISED TO HAVE A LOCAL FIRM PERSONNEL PERFORM AN IMPEDANCE CHECK PRIOR TO THE SCAN. NO FOLLOW-UP WAS REQUESTED AND IT IS UNCLEAR IF THE SCAN TOOK PLACE. IN JULY 2025 THE MEDICAL CLINIC REACHED OUT TO A NALU REPRESENTATIVE TO REPORT THAT THE PATIENT WAS BEING SCHEDULE FOR A REVISION PROCEDURE DUE TO LEAD MIGRATION. THE CLINIC DID NOT SHARE THE HISTORY OR DIAGNOSTIC METHODS FOR DETERMINING THAT THE LEADS HAD MIGRATED, HOWEVER THE PATIENT REPORTED THAT THE SYSTEM HAD NOT BEEN USED FOR MORE THAN ONE YEAR AND WAS HOPING TO REACTIVATE. ON (B)(6) 2025 THE REVISION PROVEDURE WAS PERFORMED WITH THE INTENTION OF PLACING NEW LEADS AT THE INTENDED NERVE TARGET. WHILE REMOVING THE MIGRATED LEADS, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS DAMAGED DUE TO HANDLING AND ALSO REQUIRED REPLACEMENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22768331 ↗
• InjuryAug 5, 2025Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO PAIN SYMPTOMS IN THE CHEST AREA AND EXTENDING INTO THE ARMPIT AREA. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE INFRACLAVICULAR AREA WITH THE LEADS TARGETING BILATERAL SUPRACLAVICULAR NERVES. BOTH FLUOROSCOPY AND ULTRASOUND WERE USED DURING THE IMPLANT PROCEDURE TO ASSURE APPROPRIATE PLACEMENT. AFTER IMPLANTING THE SYSTEM, THE PATIENT REPORTED DISCOMFORT AT THE SITE OF THE IPG. THE PATIENT ALSO EXPERIENCED INEFFECTIVE THERAPY DUE TO MIGRATION OF THE IMPLANTED LEADS. IN (B)(6) 2025, THE FIRM WAS NOTIFIED THAT THE PATIENT HAD ELECTED TO COMPLETELY REMOVE THE SYSTEM DUE TO THE DISCOMFORT AND LACK OF PAIN RELIEF. ON APPROXIMATELY (B)(6) 2025 THE FIRM WAS NOTIFIED THAT THE EXPLANT HAD TAKEN PLACE ON (B)(6) 2025. NO NOTIFICATION WAS RECEIVED OF THE SCHEDULED PROCEDURE AND THUS NO REPRESENTATIVE OF THE FIRM WAS ABLE TO BE PRESENT. THE EXPLANTED DEVICE WAS NOT RETAINED FOR RETURN TO NALU.

  Patient problems: Discomfort; Inadequate Pain Relief

  MAUDE report 22723533 ↗
• InjuryAug 3, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 AFTER PARTICIPATING IN A SUCCESSFUL TRIAL PHASE WITH NALU. TESTING WAS PERFORMED INTRA-OPERATIVELY TO ASSURE PLACEMENT AND FUNCTION OF THE NALU SYSTEM. AFTER USING THE SYSTEM FOR SOME TIME, THE PATIENT REPORTED NOT GETTING THE RELIEF BEING SOUGHT DESPITE MULTIPLE ATTEMPTS TO REPROGRAM AND TROUBLESHOOT. XRAY IMAGING CONFIRMED ALL IMPLANTED COMPONENTS APPEARED TO BE IN THE CORRECT POSITION, SHOWING NO SIGNS OF MIGRATION OR DAMAGE. ON (B)(6) 2025, A FULL SYSTEM EXPLANT WAS PERFORMED PER THE PATIENT'S REQUEST, DUE TO LACK OF PAIN RELIEF.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22696365 ↗
• InjuryAug 3, 2025Migration; Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. AFTER BEING IMPLANTED WITH THE NALU SYSTEM IN ARIZONA, THE PATIENT RELOCATED TO OREGON. IN JULY 2025 A NALU REPRESENTATIVE IN OREGON WAS NOTIFIED THAT THE PATIENT WOULD BE UNDERGOING A SURGICAL REVISION DUE TO MIGRATION OF THE IMPLANTED LEADS. ON (B)(6) 2025 THE PROCEDURE WAS PERFORMED AND BOTH IMPLANTED LEADS WERE REMOVED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22696364 ↗