BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 20868150 · Received December 6, 2024

    Report

    Report Number
    3006630150-2024-08525
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    November 12, 2024
    Report Date
    April 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7151780/7151784. PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180, MODEL: SC-4318, BATCH: 34570906.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE BATTERY SITE. SYMPTOMS OF INCREASED REDNESS AND SWELLING WERE NOTED. THE PHYSICIAN BELIEVED THAT INFECTION WAS PROCEDURE RELATED, AND ALSO NOTED THAT THERE WAS SOME RESIDUAL ANTIBACTERIAL SAC FROM PATIENTS PREVIOUS NON-BSC IMPLANT WHICH COULD HAVE CONTRIBUTED. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE. THE EXPLANTED DEVICE COMPONENTS WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622992 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 756420 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1