BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 14674346 · Received June 13, 2022

    Report

    Report Number
    3006630150-2022-02826
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    May 26, 2021
    Report Date
    August 9, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7072060.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT A PATIENT WHO WAS IMPLANTED WITH A WAVEWRITER ALPHA 32 SYSTEM WAS ADMITTED TO A HOSPITAL DUE TO AN UNRELATED SURGERY. DURING THE STAY IN THE HOSPITAL, THE PATIENT UNDERWENT AN MRI. FOLLOWING THE MRI, THE PATIENT'S SPINAL CORD STIMULATOR SYSTEM COULD NO LONGER ESTABLISH COMMUNICATION AND COULD NO LONGER HAVE THE STIMULATION ADJUSTED. ACCORDING TO THE PATIENT, THE BSC REPRESENTATIVES/TECHNICIANS SUSPECTED THAT THE MRI COULD'VE DAMAGED THE STIMULATOR SYSTEM OR THAT THE LEAD MIGHT'VE SLIPPED OUT OF THE IPG HEADER. AS OF NOW, THE PATIENT REMAINS IMPLANTED WITH THE SPINAL CORD STIMULATOR SYSTEM AND THERE IS NO KNOWN FURTHER COURSE OF ACTION.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT A PATIENT WHO WAS IMPLANTED WITH A WAVEWRITER ALPHA 32 SYSTEM WAS ADMITTED TO A HOSPITAL DUE TO AN UNRELATED SURGERY. DURING THE STAY IN THE HOSPITAL, THE PATIENT UNDERWENT AN MRI. FOLLOWING THE MRI, THE PATIENT'S SPINAL CORD STIMULATOR SYSTEM COULD NO LONGER ESTABLISH COMMUNICATION AND COULD NO LONGER COULD HAVE THE STIMULATION ADJUSTED. ACCORDING TO THE PATIENT, THE BSC REPRESENTATIVES/TECHNICIANS SUSPECTED THAT THE MRI COULD'VE DAMAGED THE STIMULATOR SYSTEM OR THAT THE LEAD MIGHT'VE SLIPPED OUT OF THE IPG HEADER. AS OF NOW, THE PATIENT REMAINS IMPLANTED WITH THE SPINAL CORD STIMULATOR SYSTEM AND THERE IS NO KNOWN FURTHER COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965567 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 500459 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 Female