BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3900641 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12229
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 6, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # V815657, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 37092, LOT # UNKNOWN, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS OF THE PATIENT PROGRAMMER, SERIAL # (B)(4), FOUND NO ANOMALY. ANALYSIS OF THE LEAD, LOT #V815657, FOUND THE BODY CONDUCTORS CRUSHED. THERE WAS NO SIGNIFICANT ANOMALY. ANALYSIS OF THE NEUROSTIMULATOR, SERIAL # (B)(4), FOUND THE SETSCREW BACKED OUT TOO FAR. THERE WAS NO SIGNIFICANT ANOMALY. A KNOWN GOOD LEAD WAS ATTACHED TO THE RETURNED INS AND IMPEDANCES WERE ALL NORMAL. ANALYSIS OF THE UNKNOWN ANTENNA FOUND NO ANOMALY. THE INS, ANTENNA, AND PROGRAMMER WERE TESTED TOGETHER AS A SYSTEM WITH A KNOWN GOOD LEAD. THE PROGRAMMER WAS ABLE TO TURN THE INS ON/OFF AND ALSO INCREASE/DECREASE AMPLITUDE. THE SYSTEM FUNCTIONED CORRECTLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES AND THE LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE REPLACED. THE PATIENT HAD LESS THAN 50% THERAPY RELIEF AT THE LEAD LOCATION. IT WAS NOTED THAT THE BATTERY DEPLETION WAS NORMAL. FOUR DAYS LATER, IT WAS REPORTED THAT THE IMPEDANCES WERE OVER 4,000 OHMS. THE CAUSE OF THE IMPEDANCE ISSUE WAS NOT KNOWN. SYSTEM REPLACEMENT RESOLVED THE ISSUE AND THAT PATIENT WAS FINE IN RECOVERY. THE PATIENT¿S THERAPY RESULTS WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377393 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention