BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18097592 · Received November 8, 2023

    Report

    Report Number
    3006630150-2023-06879
    Event Type
    Injury
    Date Received
    November 8, 2023
    Date of Event
    October 9, 2023
    Report Date
    November 8, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: PRECISION, UPN: M365SC9218150, MODEL: SC-9218-15, SERIAL: (B)(6), BATCH: 7071844. BRAND NAME: LINEAR 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7072930. BRAND NAME: LINEAR 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7073198. BRAND NAME: PRECISION, UPN: M365SC9218150, MODEL: SC-9218-15, SERIAL: (B)(6), BATCH: 1101391.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED MULTIPLE ILLNESSES, UNRELATED TO THE SPINAL CORD STIMULATOR (SCS) SYSTEM, SUCH AS COVID 19, PNEUMONIA, SHINGLES AND MYASTHENIA GRAVIS WHICH RESULTED IN WEIGHT LOSS AND FREQUENT FALLS ONTO HER IPG SITE. HENCE, THE IMPLANTABLE PULSE GENERATOR (IPG) IS MIGRATING WITHIN THE POCKET CAUSING SIGNIFICANT DISCOMFORT, DIFFICULTY CHARGING AND A BURNING SENSATION. THE PATIENT WILL REQUIRE AN MAGNETIC RESONANCE IMAGING (MRI) IN THE FUTURE DUE TO THEIR CURRENT CONDITION, THEREFORE THE PHYSICIAN RECOMMENDED AN EXPLANT. THE PATIENT UNDERWENT AN EXPLANT OF THE IPG, LEADS AND M8 ADAPTERS AND IS DOING WELL POST OPERATIVELY. NO DEVICES WILL BE RETURNED AS THEY WERE RETAINED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93398 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 366235 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention