BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 18557129 · Received January 22, 2024

    Report

    Report Number
    3006630150-2023-08639
    Event Type
    Injury
    Date Received
    January 22, 2024
    Date of Event
    December 26, 2023
    Report Date
    January 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    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: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7081739/7082253.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE BATTERY SITE. SYMPTOMS OF CHILLS AND TENDERNESS AT THE IMPLANT SITE WERE NOTED. THE PHYSICIAN CONFIRMED THAT INFECTION WAS NOT DEVICE RELATED HOWEVER THE CAUSE WAS UNKNOWN. INFECTION PERSISTED DESPITE THE PATIENT BEING PLACED ON ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL DEVICE COMPONENTS WERE REMOVED AND DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2052986 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1432 220734 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention