BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3213975 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11502
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    July 19, 2012
    Report Date
    May 24, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# VA015S0, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS ¿VERY UNHAPPY¿ WITH THE RESULTS. THE PATIENT FELT AS IF THE PHYSICIANS IN HER AREA DIDN¿T UNDERSTAND HOW TO MANAGE THE DEVICE. THE NEXT MONTH, THE PATIENT REPORTED IT DID NOT WORK AS SHE HAD BEEN TOLD. IT WAS FURTHER REPORTED THAT THE PATIENT WAS NO BETTER THAN BEFORE THE IMPLANT. THE PATIENT WAS CONCERNED THAT THE UNIT WAS IMPROPERLY INSTALLED OR WAS PLACED WRONG. THERE WAS CONCERN THAT SOMETHING WAS WRONG WITH THE UNIT. THE PATIENT HAD DIFFICULTY FINDING A PHYSICIAN, WHICH WAS CAUSING THE PATIENT ¿MENTAL ISSUES.¿ IT WAS STATED THAT ONE OF THE PHYSICIANS THE PATIENT SAW DID NOT KNOW HOW TO USE THE DEVICE. IT WAS STATED THAT ANOTHER PHYSICIAN GOT FRUSTRATED AFTER THE SECOND VISIT WITH THE PATIENT. THE PATIENT HAD A RETURN OF THE SHAKES AFTER THAT VISIT. THE PATIENT THEN SWITCHED TO A THIRD PHYSICIAN BUT THE PATIENT FELT NO ONE WOULD LISTEN TO HER. AT THAT FIRST VISIT IN (B)(6) 2013, THEY HOOKED IT UP AND ¿RAN IT UP SO MUCH IT PUT HER HEAD INTO A SEIZURE AND SHE COULDN¿T TALK.¿ THE PATIENT WAS IN PAIN AND IN TEARS. IT WAS STATED THAT NOW THE SIDE OF THE PATIENT¿S MOUTH AND SPEECH HAD CHANGED. THE PATIENT WAS IN THE PROCESS OF SEEKING OUT A FOURTH PHYSICIAN. IT WAS FURTHER REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS, BUT WORKING WITH HER PHYSICIAN. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2013. AS OF (B)(6) 2013, THE UNIT DID NOT WORK. THE PATIENT WAS UNHAPPY AS THERE WAS NO CHANGE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT WAS REPROGRAMMED ON (B)(6) 2013. IT WAS NOTED THERE WERE ¿NO APPARENT PROBLEMS¿ WITH THE PATIENT¿S ¿DEVICE OR LEAD.¿ THE PATIENT¿S PHYSICIAN REPORTED THE PATIENT DID NOT REQUIRE AN ¿IN DEPTH, CONSISTENT PROGRAMMING EFFORT.¿ IT WAS NOTED THE PATIENT¿S PHYSICIAN HAD NOT SEEN HER SINCE THE REPROGRAMMING SESSION AND THAT SHE ¿ONLY HAD A LEFT LEAD.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312639 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Other