BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 21063372 · Received January 2, 2025

    Report

    Report Number
    3006630150-2024-09241
    Event Type
    Injury
    Date Received
    January 2, 2025
    Date of Event
    December 7, 2024
    Report Date
    January 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 7080200/7080012. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. BATCH: 34432648.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR DEVICE GOT INFECTED. IT WAS NOTED THAT PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) BROKE THROUGH THE SKIN, SCABBED OVER, AND THEN THE SCAB FELL OFF AND DRAINED DOWN TO LEG. THE PATIENT WAS ADMINISTERED AN ANTIBIOTIC. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE IN ALL DEVICES WERE REMOVED AND WILL NOT BE RETURN AS IT WAS KEPT AT THE FACILITY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639535 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 225650 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention