BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18528250 · Received January 17, 2024

    Report

    Report Number
    3006630150-2024-00095
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    July 9, 2021
    Report Date
    January 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 5141680/7072368.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA FACILITY MEDWATCH (MW5148681) THAT THE PATIENTS IPG WAS NOT HOLDING A CHARGE. IT WAS ALSO NOTED THAT THE LEADS HAD MIGRATED AS CONFIRMED THROUGH X-RAY. THE PATIENT HAD ELECTROCUTION EPISODES, PAIN, PHYSICAL AND MENTAL ANGUISHMENT AS THE RESULT OF MALFUNCTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2052451 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 366604 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention