BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4093181 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17102
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0KLLU, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF NEUROSTIMULATOR MODEL 3058 (LOT # NJY254106H) SHOWED NO ANOMALY FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN IMPEDANCE ISSUE. IMPEDANCE TESTING, X-RAYS AND REPROGRAMMING WERE PERFORMED. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED AND REPLACED. THE DEVICE KEPT GETTING OPEN IMPEDANCES. THE LEAD WAS TESTED AND FOUND TO BE FINE SO IT WAS LEFT IN PLACE AND CONNECTED TO THE NEW BATTERY WITHOUT ISSUE AND IMPEDANCES WERE NOW WITHIN RANGE. NORMAL BATTERY DEPLETION WAS NOTED AS "NO". THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT THE PATIENT STATUS AT THE TIME OF REPORTING WAS NOTED AS ALIVE - NO INJURY. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572766 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention