BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 19102557 · Received April 13, 2024

    Report

    Report Number
    3006630150-2024-02346
    Event Type
    Injury
    Date Received
    April 13, 2024
    Date of Event
    March 19, 2021
    Report Date
    April 13, 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 Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A FEW YEARS BACK. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS; UPN: M365SC8120700, MODEL: SC-8120-70, SERIAL: (B)(6), BATCH: 201510A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL COMPONENTS WERE REMOVED. THE EXPLANTED DEVICES WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793343 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 331247 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention