BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2646374 · Received July 9, 2012

    Report

    Report Number
    3004209178-2012-05363
    Event Type
    Injury
    Date Received
    July 9, 2012
    Report Date
    June 11, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V922003, SERIAL# IMPLANTED: (B)(6) 2012, EXPLANTED: PRODUCT TYP LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COULD NOT WALK OR FUNCTION WHEN SHE HAD AN IMPLANTABLE NEUROSTIMULATOR (INS). THE INS HAD NOT HELPED THE PATIENT. THE PATIENT HAD SO MUCH PAIN THAT SHE COULD NOT WALK OR SIT UP. WHEN SHE TRIED TO SIT UP SHE FELL BACKWARD. SHE WAS STILL WEARING DIAPERS. THE PROGRAMMER SHOWED THE "CALL YOUR DOCTOR" ICON. THE PATIENT LOST HER BALANCE, SLID ON A "PUTTY PAD," LANDED "FLAT ON HER BUTT," AND WAS BROUGHT TO THE ER. THE PATIENT WAS FLUSH AND HAD WHITE STUFF SIMILAR TO MILK COMING OUT OUT OF HER MOUTH. THE STIMULATION COULD NOT BE ADJUSTED. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION 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 STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention