BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3926410 · Received July 10, 2014

    Report

    Report Number
    3004209178-2014-12788
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 18, 2014
    Report Date
    August 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE FOUND THE SETSCREW TO BE BACKED OUT TOO FAR. THE HEAD OF THE SETSCREW WAS STRIPPED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SET SCREW WOULD NOT LOCK THE LEAD IN PLACE IN THE IMPLANTABLE NEUROSTIMULATOR (INS). SEVERAL TROUBLESHOOTING TECHNIQUES WERE TRIED BUT THE LEAD WOULD STILL SLIDE OUT WITH NO RESISTANCE. IT WAS NOTED THAT THE SCREW WOULD CLICK AS IF IT WAS SCREWING DOWN BUT IT STILL WOULD NOT WORK. THE HEALTH CARE PROVIDER (HCP) SAID IT FELT DIFFERENT FROM THE INITIAL TIME THEY TRIED TO PLACE THE LEAD IN THE INS AND SCREW IT IN. IT WAS REPORTED THAT THE ACTIONS REQUIRED AS A RESULT OF THE EVENT WAS THAT THE DEVICE WAS NOT IMPLANTED. THE TROUBLESHOOTING PERFORMED WAS ADJUSTING THE SET SCREW. IT WAS STATED THAT IT WAS UNKNOWN IF THE PRODUCT ISSUES WAS RESOLVED AND UNKNOWN IF THE CAUSE OF THE ISSUE WAS DETERMINED. THE INS WAS NEVER IMPLANTED, WAS IN THE POSSESSION OF THE HOSPITAL, AND THE INS WOULD BE RETURNED. IT WAS NOTED THAT THE EVENT DID NOT INVOLVE A PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS RETURNING THE DEVICE IN THE NEXT 3 DAYS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS RETURNED TODAY WITH ALL THE PAPERWORK FILLED OUT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SCREW WOULDN¿T SCREW INTO THE TRACK AND STICK. THE HCP WOULD SCREW DOWN AND IT WOULD NOT SET AND THE LEAD WOULD SLIDE OUT OF THE INS EASILY. IT WAS NOTED THAT THERE WAS NO PATIENT DEATH, NO PATIENT INJURY, AND THE PATIENT RECOVERED WITHOUT SEQUELAE AFTER THE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404956 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR