BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3062081 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06392
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 28, 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

    (B)(4). ANALYSIS OF THE DEVICE, SERIAL #(B)(4), FOUND THE SETSCREW BACKED OUT TOO FAR.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V103132, IMPLANTED: (B)(6) 2008. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REVISION WITH A "POSSIBLE LEAD AND/OR IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT." IT WAS STATED THE INS WAS REMOVED AND THE LEAD WAS TUNNELED TO A NEW POCKET SITE. THE INS WAS THEN ATTEMPTED TO BE RE-IMPLANTED, BUT THE HEALTHCARE PROVIDER (HCP) COULD NOT TIGHTEN DOWN THE SET SCREW. IT "SEEMED AS IF THE SCREW WAS STRIPPED." AFTER MULTIPLE ATTEMPTS, IT WAS REPORTED THE HCP DECIDED TO EXPLANT THE INS AND IMPLANT A NEW INS. IT WAS ADDED THAT THERE WAS NOT NORMAL BATTERY DEPLETION. ABOUT TWO WEEKS LATER, IT WAS REPORTED THE REASON FOR THE REVISION WAS DUE TO THE INS NOT BEING IN A "GOOD PLACE" AND THAT IT "SEEMED" TO MOVE IN THE POCKET. THE PATIENT WANTED THE DEVICE MOVED TO THE OTHER SIDE OF THE BODY. THE PATIENT OUTCOME OF THE REVISION WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162112 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention