BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3204645 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-11264
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 25, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28 LOT# V061147, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THEY WERE UNSURE IF THE INS WAS WORKING. THE PATIENT LOST THE PATIENT PROGRAMMER SEVERAL YEARS AGO. THE PATIENT HAD SEEN THE MANAGING PHYSICIAN APPROXIMATELY TWO WEEKS POST IMPLANT (2007) AND HAD NOT SEEN THEM SINCE. THE PATIENT WAS INTERESTED IN HAVING THE DEVICE EXPLANTED. THE PATIENT WAS CURRENTLY IN A REHAB FACILITY FOR BACK PAIN. ADDITIONAL INFORMATION RECEIVED ON 2013 (B)(6) NOTED THAT THE PATIENT HAD BEEN DISCHARGED FROM THEIR FACILITY. PRIOR TO DISCHARGE THE PATIENT WAS SCHEDULED TO HAVE HER INTERSTIM DEVICE REMOVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT FEEL ANY STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305442 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention