BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4192533 · Received October 22, 2014

    Report

    Report Number
    3004209178-2014-20155
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    October 10, 2014
    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
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-33, LOT# VA00R0W, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RETURNED THEIR REPLACEMENT PROGRAMMER AND THERE WAS NO KNOWN COMPLAINT AGAINST THAT PROGRAMMER. ANALYSIS OF THE REPLACEMENT PROGRAMMER FOUND THAT THE DEVICE WAS GOOD AFTER PERFORMING A GENERAL CHECK. THE PATIENT ALSO RETURNED THE PROGRAMMER THAT HAD NO TELEMETRY. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LAST WEEKEND PATIENT WAS NOT ABLE TO MAKE ADJUSTMENT BOTH WITH OR WITHOUT ANTENNA ATTACHED. THE PATIENT IS TRYING TO CHANGE THE PROGRAM BUT THE PROGRAMMER WAS NOT CONNECTING TO THE NEUROSTIMULATOR (INS).NO TELEMETRY ,PATIENT TRIED NEW BATTERIES. ANOMALY APPEARS TO HAVE OCCURRED THROUGH PRODUCT USE. THE LAST TIME PATIENT MADE ANY ADJUSTMENTS WAS ABOUT 60-90 DAYS AGO WHILE AT THE HEALTH CARE PROVIDER AND IT WORKED JUST FINE. THE PATIENT HAD NOT HAD THE PROGRAMMER DROPPED NOR GOTTEN IT WET. THERE WERE NO FALLS OR TRAUMA NOTED. THE PATIENT WAS CURRENTLY NOT FEELING ANY STIMULATION. THE PATIENT ALSO NOTICED THAT LAST WEEKEND THAT HE HAD A GRADUAL RETURN OF SYMPTOMS WHICH WAS WHY HE WAS GOING TO MAKE THE ADJUSTMENTS. IT WAS LATER REPORTED THAT PATIENT RECEIVED A REPLACEMENT PROGRAMMER BUT WAS STILL NOT ABLE TO CONNECTING TO NEUROSTIMULATOR (INS) WITH AND WITHOUT THE ANTENNA. THE PATIENT WAS TOLD TO MEET WITH HEALTH CARE PROVIDER IF NOT STILL ABLE TO CONNECT TO CHECK THE BATTERY WITH A CLINICIAN PROGRAMMER. THE PATIENT HAS AN APPOINTMENT WITH HCP NEXT THURSDAY FROM THE DAY OF THIS CALL. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT PROGRAMMER WAS NOT RETURNED. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671671 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR