BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2926287 · Received January 23, 2013

    Report

    Report Number
    3004209178-2013-00859
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED THAT THE SETSCREW WAS BACKED OUT TOO FAR. THE SETSCREW WAS ALSO CROSS THREADED AND UNABLE TO BE TIGHTENED DOWN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE 'BACKED OUT' SCREW METHOD WAS ATTEMPTED SINCE THE LEAD COULD NOT BE SCREWED INTO THE IMPLANTABLE NEUROSTIMULATOR (INS) AS PREVIOUSLY REPORTED. IMPEDANCES WERE 'BAD' AND AN ATTEMPT WAS MADE TO RE-RUN WITH IMPEDANCE SET AT 2V. THE INS BATTERY RAN OUT AND WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT HAD NOT BEEN POSSIBLE TO INSERT A LEAD INTO HEADER BLOCK DURING A SURGERY. DURING THE PROCEDURE, THE EXISTING LEAD WAS CLEANED OFF AND INSERTED INTO A NEW IMPLANTABLE NEUROSTIMULATOR (INS). THE IMPEDANCES WERE "ALL BLACK LINES," SO THE LEAD WAS NOT SCREWED IN PLACE. IT WAS STATED THAT THE LEAD HAD BEEN CLEANED AND REINSERTED INTO INS, BUT AFTER TAKING THE LEAD IN AND OUT 2-3 TIMES, "IT ALMOST LOOKED LIKE SOMETHING WAS STUCK IN THE HOLE AND THE SCREW WOULDN'T EVEN CATCH." IT WAS BELIEVED THAT THE IMPEDANCES HAD BEEN >4000 OHMS AT THE TIME. IN THE END, A NEW LEAD WITH A SECOND INS WERE PUT IN. AFTER THESE REPLACEMENTS, THE ISSUE WAS RESOLVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33021 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR