BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3880876 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-11745
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #700633172:SETSCREW WAS BACKED OUT TOO FAR. THE INS PASSED THE FUNCTIONAL AND LEAD INSERTION TESTS. THE COMPLAINT COULD NOT BE DUPLICATED DURING ANALYSIS. THE LEAD THAT WAS STATED IN THE COMPLAINT, AS BEING DIFFICULT TO INSERT, WAS NOT RETURNED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). ANALYSIS OF THE NEUROSTIMULATOR INS (NJY253685H) REVEALED THAT THE SETSCREW WAS BACKED OUT TOO FAR. THE INS PASSED THE FUNCTIONAL AND LEAD INSERTION TESTS. THE COMPLAINT COULD NOT BE DUPLICATED DURING ANALYSIS. THE LEAD THAT WAS STATED IN THE COMPLAINT, AS BEING DIFFICULT TO INSERT, WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE ON THE DAY OF THE CALL, IT WAS INDICATED THAT A NEW NEUROSTIMULATOR AND A LEAD WAS PLACED. HOWEVER, THE LEAD COULD NOT BE PROPERLY INSERTED INTO THE NEUROSTIMULATOR (IPG). IT WAS REPORTED AS UNKNOWN IF IT WAS A SETSCREW ISSUE OR A LEAD INSERTION ISSUE, THE HEALTH CARE PROVIDER JUST COULD NOT GET THE LEAD CONNECTED PROPERLY, DESPITE RESEATING NUMEROUS TIMES. IT WAS THEN INDICATED THAT THEY MADE DECISION TO GO TO A 2ND IPG AND HAD NO ISSUES WITH IT. SETSCREW WAS PROPERLY TORQUED TO LIMIT. THE TELEMETRY WAS ALL GOOD. PATIENT WAS RELEASED AND ALL WAS FINE. IT WAS LATER INDICATED THAT THE PATIENT REVIEWED A DIFFERENT NEUROSTIMULATOR (IPG) FOR IMPLANT AND NO FOLLOW UP WAS NEEDED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357826 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR