BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 19312532 · Received May 14, 2024

    Report

    Report Number
    3006630150-2024-03108
    Event Type
    Injury
    Date Received
    May 14, 2024
    Date of Event
    February 12, 2024
    Report Date
    May 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 7080630/7081056.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG INCISION SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED, AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547416 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1432 223584 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention