BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2845289 · Received November 26, 2012

    Report

    Report Number
    3004209178-2012-10742
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Report Date
    October 29, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V042808, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT A MONTH PRIOR TO THE REPORT THE PATIENT HAD "TAKEN SOME WIRES OR SOMETHING OUT OF HER SKIN." THE PATIENT STATED THE WIRES WERE CLOSE TO HER SPINE WHERE THEY WERE PUT IN. THE PATIENT DID NOT FEEL ANY STIMULATION, BUT DID NOT KNOW WHAT IT SHOULD HAVE FELT LIKE, AND WAS NOT HOLDING HER URINE. THE PATIENT STATED THAT WHEN SHE HAD TO GO "IT FELT LIKE A CHILL FROM HER HEAD ALL THE WAY DOWN." THE PATIENT DID NOT REMEMBER ANY FALLS AND REPORTED SHE HAD NOT CONTACTED A HEALTH CARE PROVIDER (HCP) AFTER FEELING LIKE THE WIRES WERE OUT. 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