BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18150882 · Received November 16, 2023

    Report

    Report Number
    3006630150-2023-07088
    Event Type
    Injury
    Date Received
    November 16, 2023
    Date of Event
    May 21, 2019
    Report Date
    November 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED 3 WEEKS AFTER IMPLANT. BLOCK D6B: EXPLANT DATE: FEW YEARS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: LEADS: UPN: M365SC2408560; MODEL: SC-2408-56; SERIAL: (B)(6); BATCH: 21705112/5080887.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED FECAL AND URINARY INCONTINENCE. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A FULL EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600726 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 347648 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention