BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 15324872 · Received August 30, 2022

    Report

    Report Number
    3006630150-2022-04384
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    August 10, 2020
    Report Date
    August 30, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED COUPLE OF YEARS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS; UPN: M365SC8336500; MODEL: SC-8336-50; SERIAL: (B)(4); BATCH: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE STIMULATION COVERAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED AND ADDED ONE PADDLE LEAD AND TWO LINEAR LEADS. IT WAS ALSO NOTED THAT THE PHYSICIAN CUT THE ORIGINAL PADDLE LEAD AND DECIDED NOT TO REMOVE BECAUSE THE PHYSICIAN FELT IT WAS SAFER TO LEAVE IT. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG WAS NOT RETURNED AS IT WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300070 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 339339 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention