BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 20240655 · Received September 17, 2024

    Report

    Report Number
    3006630150-2024-06182
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    June 4, 2024
    Report Date
    September 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7123755/7123752.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE ALL DEVICES WERE REMOVED. THE EXPLANTED DEVICE WILL NOT BE RETURN AS IT WAS DISPOSED PER POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808873 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 563899 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention