BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2904824 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00370
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3387S-40 LOT# V835130, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3387S-40 LOT# V835130, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW CORRECTED THAT THE PATIENT DID NOT HAVE RETURN OF SYMPTOMS; THE PATIENT HAD SOME SYMPTOMS ON HER LEFT SIDE THAT SHE NEVER HAD BEFORE. THE PATIENT WAS NOT FEELING ANY SIDE EFFECTS OTHER THAN ¿IT JUST DID NOT FEEL RIGHT.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A RETURN OF SYMPTOMS ON THE LEFT SIDE OF THEIR BODY. THERE WERE NO KNOWN FALLS OR TRAUMA THAT CONTRIBUTED TO THE EVENT. IT WAS STATED THAT THE PATIENT TURNED THEIR HEAD TO THE LEFT AND HEARD AN INTERNAL "POP" SOUND NEAR THEIR HEAD. THE PATIENT'S ARM WAS NUMB FROM THE WRIST TO THE MID-ARM. THE PATIENT ALSO EXPERIENCED DYSKINESIA AROUND THEIR SHOULDER. X-RAYS WERE TAKEN AND EVERYTHING WAS BELIEVED TO BE "GOOD" AROUND THE RIGHT LEAD, BUT ON THE LEFT LEAD THEY NOTICED A "FINE KINK OR PINCH" ON THE X-RAY. THE PATIENT HAD AN IMPEDANCE VALUE OF 34 OHMS ON THE 8-9 BIPOLAR PAIR. C8 WAS 798 OHMS AND C9 WAS 798 OHMS. THE PATIENT WAS PROGRAMMED ON C+, 8-. REPROGRAMMING TO C+, 10- WAS ATTEMPTED BUT IT DID NOT HELP WITH SYMPTOM CONTROL. THERE WERE NO OTHER SYMPTOMS REPORTED, AND NO SHOCKS REPORTED. IT WAS STATED THAT THE IMPEDANCE ISSUE WAS NEW, AND THAT IT WASN'T AN ISSUE IN THE OPERATING ROOM. THREE DAYS LATER, IT WAS REPORTED THAT THE PHYSICIAN USED DIFFERENT CONTACTS TO OBTAIN THERAPY. THERE WAS NO INTERVENTION NEEDED AND THE DEVICE WAS NOT EXPLANTED. IT WAS STATED THAT THE PATIENT WAS "DOING WELL" NOW THAT SHE WAS REPROGRAMMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10415 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1