BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3083421 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-07036
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 11, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF PROGRAMMER MODEL # 3037, SERIAL# (B)(4) SHOWED NO ANOMALY FOUND. RESOLDERED THE ANTENNA JACK AS A PREVENTIVE MEASURE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3093-33, LOT# V196154, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THE PATIENT PROGRAMMER WOULD NOT INTERROGATE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD A RETURN OF SYMPTOMS FOR THE 3 MONTHS PRIOR TO THE REPORT. IT WAS NOTED THAT THE PATIENT HAD NOT USED THE PATIENT PROGRAMMER TO MAKE ADJUSTMENTS DURING THAT TIME. HOWEVER, AT THE TIME OF THE REPORT, THE PATIENT WAS UNABLE TO MAKE ADJUSTMENTS WITH THE PROGRAMMER. THE REPORTER STATED THAT THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMA. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED NO STIMULATION SENSATION. THE REPORTER WAS UNCERTAIN WHEN THE PROBLEM STARTED BUT STATED THAT "IT JUST QUIT WORKING" AND THE PATIENT "SUDDENLY DIDN'T FEEL IT". IT WAS FURTHER REPORTED THAT THE PATIENT LOST STIMULATION SENSATION AND BENEFIT ABOUT 6 MONTHS PRIOR TO THE REPORT. IT WAS NOTED THAT THERE WAS NO TELEMETRY POSSIBLE WITH THE PATIENT OR CLINICIAN PROGRAMMERS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184804 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR