BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2181182 · Received July 8, 2011

    Report

    Report Number
    3004209178-2011-05246
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Report Date
    June 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED NO STIMULATION SENSATION FOLLOWING A FALL ONTO THE HIP, NEAR THE LOCATION OF THE IMPLANTABLE NEUROSTIMULATOR. THE PT EXPERIENCED SORENESS AND PAIN AROUND THE DEVICE POCKET. THE PT WAS HOSPITALIZED FOR A FEW DAYS, BUT DID NOT FOLLOW UP WITH THE HEALTHCARE PROVIDER (HCP) TO HAVE THE DEVICE CHECKED. WHILE IN THE HOSPITAL, THE PT HAD SEVERAL CARDIAC TESTS AND IMAGING TO ASSESS THE HIP. THE PT WAS, SUBSEQUENTLY, NOT ABLE TO ADJUST THE STIMULATION. A "CALL YOUR DOCTOR" MESSAGE WAS DISPLAYED ON THE PT'S PROGRAMMER. IT WAS ALSO POSSIBLE THAT A POWER ON RESET (POR) CONDITION WAS ENCOUNTERED WHEN ATTEMPTING TO ADJUST THE STIMULATION. NO INFO WAS PROVIDED RELATED TO THE PT'S OUTCOME. ADD'L INFO WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGRAMMER: MODEL 3037, LOT# NJD038826N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V027285