BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERSTIM II

    MDR report key: 1662679 · Received April 16, 2010

    Report

    Report Number
    3004209178-2010-03095
    Event Type
    Death
    Date Received
    April 16, 2010
    Date of Event
    February 5, 2010
    Report Date
    March 23, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT FELL IN (B) (6) 2009 AND NOTICED AN INCREASE IN TOE CURLING. THE PT WENT TO THE ER BUT DID NOT BRING THE PT PROGRAMMER WITH. THE PT WAS UNABLE TO ADJUST STIMULATION AS WELL. THE PT CONTINUED TO HAVE THE TOE CURLING AND HAD TROUBLE WALKING. THE DEVICE HAD BEEN TURNED OFF, BUT THE PT STILL HAD TOE CURLING. FURTHER INFO RECEIVED INDICATED THAT THE PT WAS DECEASED. THE CAUSE OF DEATH WAS REQUESTED FROM THE PT'S PHYSICIAN.

    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 90 YR Death EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT #NJD074964N| LEAD: MOEL 3889, LOT #V156080