BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 13116281 · Received December 30, 2021

    Report

    Report Number
    3006630150-2021-07353
    Event Type
    Injury
    Date Received
    December 30, 2021
    Date of Event
    November 25, 2021
    Report Date
    December 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2021. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEAD, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7060545.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SUSPECTED OF AN INFECTION AT THE IPG SITE WITH SYMPTOMS OF REDNESS AND SWELLING. THE PATIENT WAS ALSO HAVING PAIN AT THE IPG SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS CAUSED BY RUBBING ON THE BELT LINE. THE PATIENT WAS GIVEN ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE WHEREIN ONLY THE IPG WAS EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND EXPLANTED IPG WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015947 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1432 204190 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention