BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11910786 · Received May 31, 2021

    Report

    Report Number
    3006630150-2021-02541
    Event Type
    Injury
    Date Received
    May 31, 2021
    Date of Event
    January 4, 2021
    Report Date
    May 31, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC833650, MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7072300. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, SERIAL: NA, BATCH: 26012422.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DESPITE MULTIPLE REPROGRAMMING ATTEMPTS. IT WAS NOTED THAT THE COVERAGE SEEMS TO AGGRAVATE PRE-EXISTING NOT DEVICE RELATED STOMACH DISCOMFORT. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR EXPLANT PROCEDURE AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. NO DEVICE MALFUNCTION SUSPECTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807095 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 375891 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention