BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2802936 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09481
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    September 25, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE NEVER WORKED SINCE IMPLANT. THE PATIENT FELT STIMULATION FOR A WHILE; HOWEVER, IT NEVER DID WHAT IT SHOULD HAVE. THE PATIENT NEVER HAD A FALL OR TRAUMA AND THE DEVICE HAD ALWAYS GIVEN HER TROUBLE. A FEW MONTHS AGO THE PATIENT FELT AN OVERSTIMULATION FEELING OUT OF THE BLUE AND THEN IT JUST STOPPED. THE PATIENT WAS NOT DOING ANYTHING OUT OF THE ORDINARY. IT WAS ALSO REPORTED THAT THE PATIENT HAD AN APPOINTMENT TODAY WITH THE DOCTOR AND MANUFACTURE REPRESENTATIVE WHO CHECKED THE DEVICE AND DETERMINED IT WAS NOT FUNCTIONING. SUBSEQUENT INFORMATION RECEIVED REPORTED THAT THE PATIENT'S BATTERY WAS DEAD. IT WAS NOTED THAT THE PATIENT HAD THE DEVICE LONG ENOUGH TO DEPLETE AT A HIGH AMPLITUDE. FURTHER INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT AS 'PRESUMED BATTERY DEPLETION.' THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THERE WAS NO PATIENT INJURY.

    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