BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3976785 · Received August 4, 2014

    Report

    Report Number
    3004209178-2014-13899
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Report Date
    July 11, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT # V945720, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER EXPERIENCED THERAPEUTIC EFFECT FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT WENT BACK TO THEIR HEALTHCARE PROFESSIONAL (HCP) FOR THEIR FOLLOW UP APPOINTMENT ON (B)(6) 2013 (PATIENT WAS NOT SURE OF THE EXACT DATE) WHERE THE DEVICE WAS CHECKED. IT WAS FOUND THAT ONE OF THE LEADS WAS BROKEN AND TRIED DOING PROGRAMMING BUT THE HCP COULD NOT MAKE IT WORK. THE DEVICE WAS TURNED OFF AND HAD BEEN TURNED OFF SINCE THEN. THE PATIENT DID NOT HAVE A CHANCE TO GO BACK TO THEIR HCP SINCE THEN DUE TO OTHER HEALTH ISSUES AND THE DEATH OF THEIR HUSBAND. IT WAS ALSO REPORTED THAT THE PATIENT FELL AND BROKE THEIR RIGHT HIP IN (B)(6) 2013 AND FELL AGAIN IN (B)(6) 2014 WHERE THEY BROKE THEIR LEFT HIP. THE PATIENT STATED THAT THEIR HCP KNEW THEY HAD THE INS DEVICE AND WHEN THEY FIXED HER HIPS NOTHING HAPPENED TO THE INS WHEN THEY ¿PUT HER BACK TOGETHER¿. IN ADDITION, THE PATIENT NOTED THAT WHEN THEY FELL THEY DID NOT HURT HER KNEE BUT NOW THEY NEEDED TO HAVE RIGHT KNEE SURGERY AND AN MRI. THE PATIENT ALSO STATED THAT THEY STILL COULD NOT WALK WITHOUT A WALKER. WHEN CONTACTED FOR FOLLOW UP, THE INFORMATION RECEIVED ON (B)(4) 2014 REPORTED THAT THEY WERE UNAWARE OF THE¿ BREAK¿ AND THAT THE PATIENT WAS LAST SEEN ON (B)(6) 2013 FOR THE SYMPTOM OF ¿DISTRIBUTION OF SENSATION.¿ IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453402 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR