BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3004519 · Received March 14, 2013

    Report

    Report Number
    3004209178-2013-03726
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 21, 2013
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V802404, IMPLANTED: (B)(6) 2012, 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 THERE WAS A SHOCKING OR JOLTING SENSATION. THE PATIENT REPORTEDLY HAD TO GO TO THE EMERGENCY ROOM THE NIGHT PRIOR TO THE REPORT BECAUSE SHE WAS FEELING A SHOCKING SENSATION "EVERY 90 SECONDS." IT WAS NOTED THAT THE PATIENT TURNED THE DEVICE OFF WHEN SHE HAD SURGERIES ON (B)(6) 2013 TO "HAVE HER OVARIES AND TUBE REMOVED." AFTER SURGERY, THE DEVICE WAS TURNED ON BUT THE PATIENT "GRADUALLY FELT AN INCREASE IN STIMULATION." THE PATIENT REPORTED WAS FEELING COMFORTABLE STIMULATION AFTER DECREASING SETTINGS. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED THAT THE PATIENT HAD HER DEVICE TURNED OFF FOR SURGERY AND WHEN IT WAS TURNED BACK ON, THE LEVEL WAS AT 8.5 V. IT WAS INDICATED THAT THE EVENT WAS ATTRIBUTED TO HIGH STIMULATION INTENSITY, THAT STIMULATION WAS TURNED UP BY A NURSE POST-SURGERY TO AN INCORRECT LEVEL. THE PATIENT'S CAREGIVER CALLED AND WAS WALKED THROUGH ON HOW TO TURN DOWN STIMULATION BY THE MANUFACTURER. IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THE PATIENT OUTCOME WAS REPORTED AS NO INJURY. THE PATIENT WAS DOING WELL WITH THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107742 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR