BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 1526501 · Received November 2, 2009

    Report

    Report Number
    6000032-2009-07954
    Event Type
    Injury
    Date Received
    November 2, 2009
    Date of Event
    January 1, 2001
    Report Date
    October 5, 2009
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED SEVERAL GRAND MAL SEIZURES BEGINNING APPROXIMATELY ONE YEAR AFTER IMPLANTATION. FOLLOWING PROGRAMMING ADJUSTMENTS THIS YEAR (VOLTAGE INCREASED FROM 3 TO 3.6) AND 2 MONTHS LATER (UNCLEAR ADJUSTMENTS), ADD'L GRAND MAL SEIZURES OCCURRED, THE LAST REPORTED TO HAVE OCCUR SEPT. A CT SCAN AND EEG WERE PERFORMED; CT SCAN RESULTS WERE NOT REPORTED, EEG RESULTS WERE UNCLEAR DUE TO INTERFERENCE. THE PT WAS PLACED ON ANTI-CONVULSION MEDICATION AND IS NOW CONSIDERED EPILEPTIC. IT WAS REPORTED THAT THE PT IS SENSITIVE TO MEDICINE AND HAS PARADOXICAL REACTIONS TO MANY MEDICATIONS. IT WAS ALSO REPORTED THAT THE PT'S (UNSPECIFIED) SYMPTOMS RETURNED AND THE "INTERNAL BATTERY APPEARS TO HAVE DIED." ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL II LGW MDT PUERTO RICO OPERATIONS CO, MED REL 7424 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD: MODEL 3387, LOT#: L69415| PROGRAMMER: MODEL PROGRAMMER, LOT#: UNK| EXTENSION: MODEL 7495-51, LOT#: XR0069885N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED: