BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2844866 · Received November 26, 2012

    Report

    Report Number
    3004209178-2012-10734
    Event Type
    Injury
    Date Received
    November 26, 2012
    Report Date
    October 28, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-33 LOT# V328412, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS DEAD AND NO LONGER HAD A CHARGE. THE PATIENT RECEIVED "STIMULATION CHARGES" FROM THE DEVICE THAT "CAUSED SEIZURES." THE PATIENT WAS HOSPITALIZED AT THE TIME OF THE REPORT AND IT WAS REPORTED THAT HER DEVICE HAD "MOVED" AND HER WIRES WERE "POKING OUT." THE PATIENT'S RIGHT ARM AND HAND WERE NUMB AND THE NUMBNESS WAS "MOVING" TO OTHER PARTS OF HER BODY. THE PATIENT STATED, SHE BEGAN HAVING SEIZURES THREE WEEKS PRIOR TO THE REPORT, BUT SHE ALSO STATED THAT THE HEALTH CARE PROVIDERS (HCP) SAID IT WAS NOT SEIZURES. THE DEVICE WAS ALSO REPORTED AS "STICKING OUT OF THE PATIENT'S REAR END" AND WAS "SHOCKING OR JERKING" HER. THIS TOOK THE PATIENT "TO HER KNEES AND THREW HER INTO SPASMS," WHICH WAS RELATED TO THE REASON SHE HAD THE IMPLANT. THE PATIENT STATED, THE DEVICE WAS CAUSING "LIFE THREATENING ISSUES" AND NEEDED TO BE REMOVED. THE PATIENT STATED, SHE HAD BEEN TO TWO DIFFERENT HOSPITALS IN THE TWO DAYS PRIOR TO THE REPORT. THE PATIENT WAS BEING RELEASED AND STILL NEEDED THE ISSUE ADDRESSED. THE PATIENT STATED "IT COULD KILL HER," SHE WAS NOT COMFORTABLE, AND WAS "FREAKING OUT." TWO DAYS PRIOR TO THE REPORT, THE PATIENT HAD AN ELECTROENCEPHALOGRAM (EEG) AND A COMPUTED AXIAL TOMOGRAPHY (CAT) SCAN THAT SHOWED SHE HAD "FIVE SEIZURES" AND SHE WAS MOVED TO THE EMERGENCY ROOM (ER) AS A "CODE RED" AND IT GOT UNDER CONTROL. THE PATIENT STATED, SHE GOT UP THE DAY PRIOR TO THE REPORT AGITATED AND HAD A "FULL BLOWN SEIZURE." THE HOSPITAL DETERMINED IT WAS A SEIZURE, BUT RELEASED HER AND THE HOSPITAL SHE WENT TO AFTER ALSO PLANNED TO RELEASE HER. THE PATIENT STATED, SHE KNEW THE DEVICE WAS DEAD BECAUSE, HER PATIENT PROGRAMMER "TOLD HER¿ AND SHE HAD NOT HAD ANY HCP INTERROGATE THE DEVICE SINCE IMPLANT. THE PATIENT REITERATED THAT HER WIRES WERE "STICKING UP IN HER SKIN" AND SHE "LITERALLY FELT THEM ROLLING AROUND." THE PATIENT ALSO STATED, HER PACEMAKER WAS CAUSING SERIOUS ISSUES. THE PATIENT STATED THAT THREE HCPS HAVE TOLD HER IT WAS NOT THE PACEMAKER AND THAT HER SEIZURES "JUST HAPPEN" AND SHE HAS TO "LET THEM PASS." THE PATIENT STATED THAT THE HCPS THOUGHT "SHE WAS A LUNATIC" WHEN SHE DESCRIBED HOW THE THERAPY WORKED, BUT SHE DID HAVE A "MENTAL ISSUE" SHE WAS WILLING TO ADMIT. THAT PATIENT STATED, SHE HAD "NEVER" HAD SEIZURES BEFORE AND BECAUSE HER WIRES WERE "ROLLING" SHE FELT THERE WAS SOMETHING THAT "NEEDED TO BE SEEN." THE PATIENT STATED THEY WOULD NOT TAKE AN X-RAY, BUT SHE WANTED IT TO BE DONE. 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 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O