BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 2874045 · Received December 14, 2012

    Report

    Report Number
    3007566237-2012-03018
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS TO GET HER DEVICE REMOVED THE DAY OF THE REPORT, BUT BOTH SHE AND HER HUSBAND WERE SICK AND THROWING UP SO THE SURGERY WAS CANCELLED. THE PATIENT WAS 'LEAVING' AND SWIMMING SEASON STARTED SOON SO THE PATIENT WAS GOING TO WAIT UNTIL (B)(6) 2013 TO HAVE SURGERY. THE PATIENT HAD THE DEVICE OFF FOR ABOUT A YEAR AND HALF AND IT NEVER REALLY HELPED WITH SYMPTOMS. THE PATIENT ALSO HAD PERIPHERAL NEUROPATHY SO SHE 'SOMETIMES' DID NOT FEEL STIMULATION AND 'SOMETIMES' IT FELT LIKE SHE WAS GETTING 'SHOCKED,¿' SO IT WAS NOT 'REALLY WORTH IT' TO HER. AT THE TIME OF THE REPORT THE PATIENT 'COULD NOT BE HAPPIER' AND WAS FINE. AFTER REVIEWING THE FILE IT WAS DETERMINED THAT MANUFACTURING REPORT #3004209178-2013-03766 WAS RELATED. THIS RELATED REPORT CONTAINS ANY REPORTABLE INFORMATION NOT REPORTED HERE. ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED THROUGH THIS FILE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU). THE PATIENT SUFFERED THREE GRAND MAL SEIZURES, WAS INCOHERENT, HER BLOOD PRESSURE WAS "OUT OF CONTROL," AND THE LATEST COMPUTED TOMOGRAPHY (CT) SCAN INDICATED "CHANGES." THE HEALTH CARE PROVIDER (HCP) WANTED TO TAKE A MAGNETIC RESONANCE IMAGE (MRI), SO THE DEVICE NEEDED TO BE REMOVED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention