BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2857235 · Received December 4, 2012

    Report

    Report Number
    3004209178-2012-11173
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT # V251861, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PREVIOUS MONTH THE PATIENT HAD FIRST SEEN A POWER-ON-RESET (POR) CONDITION AND A CALL-YOUR-DOCTOR MESSAGE ON THE PROGRAMMER. NO DIAGNOSTIC IDENTIFIER WAS REPORTED. THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION DUE TO THE POR CONDITION. APPROXIMATELY 2 WEEKS AFTER THE INITIAL REPORT IT WAS REPORTED THE POR CONDITION HAD NOT BEEN CLEARED. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2012. THE PHYSICIAN THE PATIENT HAD WENT TO DID NOT KNOW HOW TO CLEAR THE POR. THE PATIENT FELT THAT THE DEVICE WAS ON, AND WAS LOOKING TO TURN THE DEVICE OFF PRIOR TO AN UNRELATED SURGERY. IT WAS REPORTED THE PATIENT HAD LEAKAGE OF URINE AT THE TIME. THE PATIENT STILL HAD CONCERNS REGARDING THE DEVICE AND WAS GOING TO "START THE PROCESS" OF GETTING A REPLACEMENT AFTER RECOVERY FROM THE UNRELATED SURGERY, AND AN ANNUAL PHYSICAL. NO REPLACEMENT WAS SCHEDULED.

    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