BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2211072 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-06088
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 22, 2011
    Report Date
    November 17, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION COULD NOT BE ADJUSTED. THERE WAS A DISPLAY SHOWING A "CALL YOUR DOCTOR" ICON. THERE WAS AN OOR CONDITION BUT THE PT HAD NOT NOTICED ANY CHANGES IN THERAPEUTIC EFFECT. IMPEDANCE WERE DONE AND A SHORT CIRCUIT WAS DETECTED ON CONTACTS 1,2 WHICH WERE THE CONTACTS FOR GROUPS B AND C AND USED 100% OF THE TIME BY THE PT. LOW IMPEDANCES OF 250 - 2000 OHMS ON THE UNIPOLAR RANGE AND 250 - 4000 OHMS ON THE BIPOLAR RANGE FOR ELECTRODES 1,2 WERE REPORTED. THE PT WOULD CONTINUE TO GET OOR IF GROUPS B AND C WERE USED. THERE WAS A POTENTIAL NEED FOR A SURGICAL REVISION. X-RAYS WERE TAKEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED INDICATED THAT THE PATIENT HAD REVISION SURGERY OF HER EXTENSIONS AND INS, FOLLOWING THE OOR CONDITION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED, WHICH CONFLICTS WITH PREVIOUS INFORMATION REPORTED. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT WAS AT THE GYM IN (B)(6) OF 2010 WHEN HE FELT A SNAPPING, AS IF HED PULLED A MUSCLE. THE PATIENT WENT IN AND HAD THE LEFT LEAD AND NEUROSTIMULATOR REPLACED ON (B)(6), 2010. THE PATIENT DID NOT HAVE THE LEAD REPLACEMENT INFORMATION. THE COMPANY'S DEVICE REGISTRATION SYSTEM SHOWED ONLY THAT THE NEUROSTIMULATOR WAS REPLACED ON (B)(6), 2011. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT #V348020| IMPLANTED:| EXTENSION: MODEL 38085, LOT #NKN003302V| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT #V348020| EXTENSION: MODEL 37085, LOT #NKN003474V