BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2842800 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10665
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 26, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3889-28 LOT# VA01HA3, IMPLANTED: 2012 (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 HAD A LOSS OF THERAPEUTIC EFFECT ABOUT TWO TO THREE WEEKS PRIOR TO THE REPORT AND EXPERIENCED A RETURN IN SYMPTOMS. THE PATIENT WAS USING THE BATHROOM "EVERY ONE TO TWO HOURS" AND WHILE TRAVELING THERE WERE TIMES WHEN HE HAD TO "USE A BUSH." THE PATIENT THOUGHT THE TRIAL WAS BETTER AS HE WAS GOING TO THE BATHROOM "EVERY TWO TO THREE HOURS." THE PATIENT WAS ASSISTED IN CHANGING PROGRAMS AND FELT STIMULATION AT 4.5 VOLTS. THE PATIENT WANTED TO INCREASE TO 5.0 VOLTS, BUT STARTED TO FEEL "NAUSEOUS," SO ADJUSTED IT BACK TO 4.5 VOLTS. THE PATIENT WAS TO ASSESS HIS SYMPTOMS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HIS DEVICE OR THERAPY, BUT WAS WORKING WITH HIS HEALTH CARE PROVIDER OR MANUFACTURER REPRESENTATIVE. HOWEVER, IT WAS UNCLEAR IF THIS WAS ACCURATE BECAUSE, THE PATIENT ALSO MARKED THAT HE WAS STILL HAVING CONCERNS, BUT HAD NOT SOUGHT FURTHER HELP. 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