BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 21226240 · Received January 23, 2025

    Report

    Report Number
    3006630150-2025-00181
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    October 15, 2024
    Report Date
    April 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: INFINION CX. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 5072154.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: INFINION CX. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 5072154. UNIQUE IDENTIFIER (UDI) # (B)(4). THE RETURNED IPG WAS ANALYZED AND FOUND TO BE IN THE EOS STATE. HOWEVER, THE ANALYSIS OF THE DATA LOG INDICATED THAT THE IPG REACHED ITS EOS 1 YEAR, 4 MONTHS, AND 2 DAYS AFTER THE INITIAL PROGRAMMING. THE AVERAGE ENERGY USE INDEX (EUI) RECORDED WAS 39.1, ALIGNING WITH AN ESTIMATED THEORETICAL BATTERY LIFESPAN OF 9 MONTHS AND 21 DAYS. THIS INDICATES THAT THE BATTERY'S LIFESPAN FELL WITHIN THE PROJECTED RANGE. ADDITIONALLY, THE IPG DISPLAYED TYPICAL FEATURES DURING THE VISUAL AND FUNCTIONAL INSPECTION. VISUAL AND X-RAY INSPECTION OF THE RETURNED LEAD REVEALED THAT THIS LEAD WAS BENT/KINKED NEAR THE SET SCREW MARK OF THE CLIK ANCHOR AND MULTIPLE CABLES WERE COMPLETELY BROKEN AT THIS LOCATION. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. LABORATORY ANALYSIS DETERMINED THAT THE CAUSE OF THE BROKEN CABLES IS DUE TO MECHANICAL STRESS FROM POSSIBLE FLEXING OF THE LEAD AT THE EXIT POINT OF THE CLIK ANCHOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT RECEIVED THE ELECTIVE REPLACEMENT INDICTOR (ERI) AND END OF LIFE (EOL) MESSAGES FOR THEIR NON-RECHARGEABLE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS INITIALLY STATED THAT PATIENT EXPERIENCED INADEQUATE STIMULATION AND A RETURN OF THEIR PRE-EXISTING PAIN. IT WAS LATER THEN STATED BY THE PAIN NURSE THAT IT WAS VERY HARD TO GET A CLEAR ANSWER FROM THE PATIENT ON WHETHER THEY HAD ANY STIMULATION ISSUES. THE NON-RECHARGEABLE IPG HAD TO BE REPLACED. PRE-OPERATIVELY, IT WAS NOTED THAT THE LEAD DISPLAYED HIGH IMPEDANCES ON MULTIPLE CONTACTS. THEREFORE, THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE BOTH THE IPG AND LEAD. POST OPERATIVELY, THE PATIENT WAS NOTED TO HAVE RECOVERED AND RECEIVING PAIN RELIEF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT RECEIVED THE ELECTIVE REPLACEMENT INDICTOR (ERI) AND END OF LIFE (EOL) MESSAGES FOR THEIR NON-RECHARGEABLE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS INITIALLY STATED THAT PATIENT EXPERIENCED INADEQUATE STIMULATION AND A RETURN OF THEIR PRE-EXISTING PAIN. IT WAS LATER THEN STATED BY THE PAIN NURSE THAT IT WAS VERY HARD TO GET A CLEAR ANSWER FROM THE PATIENT ON WHETHER THEY HAD ANY STIMULATION ISSUES. THE NON-RECHARGEABLE IPG HAD TO BE REPLACED. PRE-OPERATIVELY, IT WAS NOTED THAT THE LEAD DISPLAYED HIGH IMPEDANCES ON MULTIPLE CONTACTS. THEREFORE, THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE BOTH THE IPG AND LEAD. POST OPERATIVELY, THE PATIENT WAS NOTED TO HAVE RECOVERED AND RECEIVING PAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859149 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 214677

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention