BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2983340 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03165
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 6, 2013
    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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37085-40 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 37085-40 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3387S-40 LOT# V595266, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD A DENTAL X-RAY OR PANORAX ABOUT 2 WEEKS PREVIOUSLY AND THEN FIVE DAYS PRIOR TO THE REPORT THE PATIENT STARTED HAVING "INTENSE SHAKING, EXTREME DIZZINESS, AND EYES BLURRED TO THE POINT WHERE SHE COULD NOT DRIVE". IT WAS ALSO STATED THAT ON (B)(6) 2013, THE PATIENT STARTED FEELING A SHOCKING AT THE IMPLANT SITE WHEN SHE TOUCHED THE DEVICE AND HAS HAD "LITTLE SHOCKS" EVERY DAY SINCE. IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS AFFECTING HER BREATHING AND SHE WAS GETTING HEADACHES. ADDITIONALLY, IT WAS STATED THAT THE PATIENT THOUGHT SHE WAS HAVING A "HEART ATTACK" A FEW DAYS PRIOR. THE PATIENT WAS DIRECTED TO CONTACT A PHYSICIAN AS SOON AS POSSIBLE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH HER PHYSICIAN THE FOLLOWING WEEK. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING DEVICE OR THERAPY. IT WAS UNCLEAR IF FURTHER HELP HAD BEEN SOUGHT. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE PATIENT ¿COULDN¿T REMEMBER ANYTHING,¿ AND HADN¿T FELT ¿GOOD.¿ THE INS FELT HEAVY IN THE PATIENT¿S CHEST, AND THE SHOCKING BEGAN WHEN THE PATIENT TOUCHED THE INS AND MOVED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87059 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention