BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2200845 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06146
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT FELL, RESULTING IN LEAD MIGRATION WHICH REQUIRED REVISION SURGERY. THE REVISION WAS CONDUCTED ON (B)(6) 2011. FOLLOWING REVISION SURGERY, THERAPY WAS EFFECTIVE FOR SIX WEEKS, AT WHICH POINT, THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND COULD NOT LONGER FEEL STIMULATION EVEN AT HIGH AMPLITUDES. THE PT HAD NO FALLS OR TRAUMA AFTER REVISION SURGERY. THE PT ALSO EXPERIENCED "STINGING PAIN" AT THE NEUROSTIMULATOR SITE WHILE THE DEVICE WAS BOTH ON AND OFF. THE PAIN BEGAN AFTER THE REVISION SURGERY. MOVING THE NEUROSTIMULATOR UP AND DOWN IN THE POCKET DID NOT CHANGE THE PAIN. THE DEVICE WAS OFF. AN X-RAY TAKEN ON (B)(6) 2011 DID NOT SHOW THAT THE LEAD HAD MIGRATED. REPROGRAMMING HAD BEEN PERFORMED BUT WAS NOT SUCCESSFUL. IMPEDANCE WERE AROUND 606 OHMS (AT 2.0 V AND PULSE WIDTH OF 300). ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention EXPLANTED:| LEAD: MODEL 3093, LOT# V575375| IMPLANTED:| LEAD: MODEL 3093, LOT# V552242| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD118348N| IMPLANTED: