BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4200449 · Received October 24, 2014

    Report

    Report Number
    3004209178-2014-20364
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    October 3, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V000828, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LAST TWO DAYS PRIOR TO THE REPORT THE PATIENT NOTICED HE HAD BEEN GOING TO THE BATHROOM MORE OFTEN. HE HAD BEEN HAVING URINARY SYMPTOMS, SO HE WANTED TO TRY A DIFFERENT PROGRAM. HOWEVER, HE WAS ONLY GETTING THE POOR COMMUNICATION SCREEN ON HIS PROGRAMMER. HIS PROGRAMMER WOULD NOT SYNC WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THIS STARTED A FEW MINUTES PRIOR TO THE REPORT. UPON RETURN OF THE PROGRAMMER ANALYSIS WAS UNABLE TO VERIFY THE ISSUE. THE ANTENNA JACK WAS RESOLDERED AS A PREVENTATIVE MEASURE. C100. NO INTERVENTIONS OR THE PATIENT OUTCOME WERE REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S BATTERY HAD NORMAL BATTERY DEPLETION. THE PATIENT WAS UNHAPPY WITH THE LONGEVITY OF THE BATTERY. DIAGNOSTIC TESTING OR TROUBLE SHOOTING WAS PERFORMED AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS DEAD SO IT WOULDN¿T CONNECT WITH THE PROGRAMMER. IT WAS UNKNOWN IF THE PRODUCT ISSUE WAS RESOLVED AND IT WAS UNKNOWN IF THE CAUSE OF THE ISSUE WAS DETERMINED. THE INS WAS IMPLANTED AND REMAINED IN SERVICE. THE PATIENT WAS ALIVE WITH NO INJURY AND THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT 2010 WAS THE IMPLANT YEAR OF THE DEVICE. THE DEPLETED IMPLANT WAS STILL IN THE PATIENT AT THIS MOMENT AS FAR AS THE MANUFACTURER REPRESENTATIVE WAS AWARE. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT STATES IT WAS DETERMINED THAT HIS INS(STIMULATOR) WAS "DEAD", REACHED END OF BATTERY LIFE. THE PATIENT WAS SENT A NEW PROGRAMMER FROM REPAIR, BUT PATIENT STILL HAD SAME ISSUES MENTIONED, SO HE FOLLOWED UP WITH HCP (HEALTHCARE PROVIDER) AND I T WAS DETERMINED INS HAD REACHED END OF BATTERY LIFE. THE PATIENT STATES HE WAS CALLING TODAY TO SEE IF HE CAN HAVE AN MRI OF HIS KNEE. HE ALREADY HAS HAD EXPLORATORY SURGERY ON KNEE, BUT AN MRI MAY BE NEEDED TO FURTHER DETERMINE ISSUE WITH KNEE. MRI WAS NOT RELATED TO MANUFACTURER DEVICE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678735 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR