BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3973595 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13835
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# V243044, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37092, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT CONNECT WITH THEIR PATIENT PROGRAMMER AND THEY WERE UNABLE TO ADJUST STIMULATION. THE PATIENT WENT TO THE DENTIST TODAY AND TURNED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) OFF AND NOW THEY COULD NOT TURN IT BACK ON. IT WAS NOTED THAT THE PATIENT USED THE ANTENNA AND WAS ONLY GETTING THE POOR COMMUNICATION INFORMATION SCREEN AND TRIED CONNECTING WITHOUT THE ANTENNA AND STILL HAD THE POOR COMMUNICATION SCREEN. THE PATIENT HAD NO FALLS OR TRAUMA AND DID NOT HAVE PROBLEMS COMMUNICATING THIS MORNING WHEN THEY TURNED IT OFF. IT WAS REPORTED THAT THE PATIENT JUST PRESSED THE OFF BUTTON WITHOUT PRESSING THE SYNC BUTTON TO TURN IT OFF. THE PATIENT HAD NOT STIMULATION SENSATION AND THEY DIDN¿T FEEL IT PULSATING. IT WAS STATED THAT THE PATIENT DIDN¿T PAY ATTENTION TO IT BECAUSE THEY KEPT THE SETTING LOW AND IF THEY TURNED IT UP IT WAS TOO MUCH. THE PATIENT GUESSED THEY STOPPED FEELING THE STIMULATION WHEN THEY TURNED IT OFF THIS MORNING BEFORE THEIR DENTAL APPOINTMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD POOR TELEMETRY WITH AND WITHOUT THE ANTENNA. THE ANOMALY APPEARED TO HAVE OCCURRED THROUGH PRODUCT USE AND THERE WAS NO INDICATION OF PATIENT HARM. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NOT ABLE TO CONNECT BOTH WITH AND WITHOUT THE ANTENNA ATTACHED WITH THE REPLACEMENT PROGRAMMER THAT WAS JUST SENT TO THEM. IT WAS NOTED THAT THE ANTENNA WAS DAMAGED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DAMAGED THEIR PROGRAMMER ANTENNA. THE ANTENNA WAS NOT RETURNED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RETURNED THEIR REPLACEMENT PROGRAMMER WITH NO KNOWN SPECIFIC COMPLAINT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S ORIGINAL PROGRAMMER WAS NOT RETURNED. ANALYSIS OF THE REPLACEMENT PROGRAMMER SHOWED THAT THE DEVICE TESTED OK TO THE SPECIFICATIONS. THE ANTENNA JACK WAS RESOLDERED AS A PREVENTATIVE MEASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449779 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR