BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 21612849 · Received March 14, 2025

    Report

    Report Number
    3006630150-2025-01560
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 14, 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
    LA, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7151786/7152433. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. BATCH: 35107836.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE INFECTION IS NOT DEVICE RELATED AND WAS NOT CAUSED BY THE RECENT SCS IMPLANT PROCEDURE. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE MEDICAL FACILITY DID NOT RELEASE THE EXPLANTED PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642071 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 226827 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention