BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 12151155 · Received July 12, 2021

    Report

    Report Number
    3006630150-2021-03711
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    June 14, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7070046. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7070084 AND 7070153 AND 7070224.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION CAUSING INADEQUATE PAIN RELIEF. REPROGRAMMING WAS DONE BUT DID NOT RESOLVE THE INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE SYSTEM WAS REMOVED. THE PATIENT IS DOING WELL POST OPERATIVELY. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS TO THE MANUFACTURER AS THEY WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049467 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 361709 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention