BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3070822 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06638
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    May 22, 2013
    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

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO SIGNIFICANT ANOMALY. IT WAS FOUND THAT THE BATTERY WAS AT NORMAL END OF LIFE AND HAD NO TELEMETRY OR OUTPUT. ANALYSIS OF THE LEAD FOUND NO SIGNIFICANT ANOMALY. IT WAS FOUND THAT THE #3 CONDUCTOR WIRE WAS BROKEN 5.4CM FROM DISTAL END, IT WAS SUSPECTED TO BE EXPLANT DAMAGE. A FUNCTIONAL TEST OF THE LEAD FOUND CIRCUITS 0 THRU 2 HAD ACCEPTABLE CONTINUITY AND CIRCUIT 3 WAS OPEN. THE CONDUCTOR WIRES WERE FOUND TO BE STRETCHED, THIS WAS SUSPECTED TO BE DAMAGE FROM EXPLANT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V571888, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS NORMAL BATTERY DEPLETION. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO TELEMETRY COULD BE ATTAINED WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED THAT "LAST STIM WAS A LONG TIME AGO." THE INS WAS REPORTED AS "SHALLOW" IN THE POCKET. BOTH A CLINICIAN AND PATIENT PROGRAMMER WERE USED AND HAD THE SAME TELEMETRY ISSUE. IT WAS INDICATED THAT "NOTHING REMARKABLE" OCCURRED TO THE PATIENT. THE PATIENT WAS GETTING THERAPY AND THEN IT "JUST STOPPED." A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT¿S BATTERY AND LEAD WERE REPLACED ON (B)(6) 2013. EVERYTHING REPORTEDLY TESTED "WELL".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S BATTERY WAS DEPLETED AND WAS SCHEDULED FOR A REPLACEMENT ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172388 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention