BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 12391532 · Received August 31, 2021

    Report

    Report Number
    3006630150-2021-04872
    Event Type
    Injury
    Date Received
    August 31, 2021
    Date of Event
    July 20, 2017
    Report Date
    August 31, 2021
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED SEVERAL YEARS AGO FROM THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 5171973/5172199.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS IPG WAS DIFFICULT TO CHARGE AND NEEDED TO BE CHARGED MORE FREQUENTLY. IT WAS ALSO NOTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE STIMULATION COVERAGE DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REPLACEMENT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED SCS SYSTEM WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298446 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 359356 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention