BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2942016 · Received February 4, 2013

    Report

    Report Number
    3004209178-2013-01259
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# V963079, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD NOT SEEN THEIR HEALTH CARE PROVIDER (HCP) SINCE THEIR FOLLOW-UP VISIT AND THE PATIENT ONLY HAD ONE PROGRAM IN THEIR DEVICE. IT WAS NOTED AFTER THE FIRST 1-2 MONTHS THE DEVICE WAS "NOT WORKING AS WELL." IT WAS ALSO NOT THAT THE PAST 4-5 MONTHS THE DEVICE "DID NOT SEEM TO BE WORKING AT ALL." IT WAS NOTED WHEN THE PATIENT REACHED AROUND TO FEEL THE DEVICE IT WAS "IN A BUNCH AND IT DID NOT STAY IN PLACE." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THERE WAS MOVEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) AND INCREASED SYMPTOMS OF URGENCY/INCONTINENCE. IT WAS STATED THAT THERE WAS INS INVERSION (FLIPPING) AND THE PATIENT DID NOT WANT THE DEVICE ADJUSTED. IT WAS ALSO STATED THAT THE PATIENT WAS REPROGRAMMED TO -1 AND +3 AND THE PATIENT WILL WATCH FOR IMPROVEMENT. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45918 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR