BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 17852090 · Received October 2, 2023

    Report

    Report Number
    3006630150-2023-05970
    Event Type
    Injury
    Date Received
    October 2, 2023
    Date of Event
    September 11, 2023
    Report Date
    December 7, 2023
    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
    LA, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138350 MODEL: SC-3138-35 SERIAL: (B)(6). BATCH: 5178278/7071567/7071568/7071628.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IPG WOULD NOT CHARGE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE WHEREIN ALL LEAD EXTENSIONS WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IPG WOULD NOT CHARGE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE WHEREIN ALL LEAD EXTENSIONS WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977060 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 345919 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention