BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3221231 · Received July 11, 2013

    Report

    Report Number
    3004209178-2013-11628
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 18, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 3387-40 LOT# J0424953V, IMPLANTED: 2004 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3387-40 LOT# J0217111V, IMPLANTED: 2004 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD A STROKE ABOUT 1.5 TO 2 MONTHS PRIOR TO THIS REPORT. IT WAS NOTED, THE PATIENT HAD BAD TREMORS ON THE LEFT SIDE AND THE TREMORS WERE ¿REALLY BAD¿ THE WEEK PRIOR TO THIS REPORT. IT WAS FURTHER NOTED, THE TREMORS WERE ON BOTH SIDES. IT WAS NOTED, THE PATIENT PROGRAMMER HAD BEEN STOLEN. THE REPORTER STATED, THEY THOUGHT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS OFF AND HAD NOT TAKEN A CHARGE. IT WAS LATER REPORTED THAT THE PATIENT HAD TREMORS THAT RETURNED WITHIN THE WEEK PRIOR TO THIS REPORT. THE NEXT DAY, IT WAS REPORTED THAT THE PATIENT FELT A SHOCKING SENSATION WHEN THE INS WAS TURNED ON. IT WAS NOTED, THE SHOCKING SENSATION REMAINED AFTER A FEW MINUTES. THE REPORTER STATED IF THE SHOCKING CONTINUED THEY WOULD TURN THE INS OFF. IT WAS LATER REPORTED THAT STIMULATION WAS TURNING OFF DURING THE WEEK PRIOR TO THIS REPORT. IT WAS NOTED, THE PATIENT¿S PROBLEMS WERE RESOLVED AND THE PATIENT WAS RECEIVING THERAPY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2013 FOR A STROKE AND THE PATIENT WAS EXPERIENCING RIGHT-SIDED WEAKNESS AT THAT TIME. IT WAS NOTED THAT THE PATIENT HAD TWO CAT SCANS WHILE AT THE HOSPITAL AND THERE WAS NO EVIDENCE OF A STROKE. IT WAS REPORTED THAT THE PATIENT HAD A SEIZURE WHILE BEING HOSPITALIZED AND THEY SUSPECTED THAT THE PATIENT HAD NOT EXPERIENCED A STROKE BUT RATHER A SEIZURE THAT HAD STARTED IN THE LEFT BRAIN, WHICH WAS THE REASON FOR THE RIGHT-SIDED WEAKNESS. THE REPORTER STATED THAT SEIZURES WERE NOT CONSIDERED TO BE DEVICE RELATED, THE PATIENT WAS PUT ON KEPPRA FOR SEIZURES, AND WAS DISCHARGED ON (B)(6) 2013. IT WAS NOTED THAT THE PATIENT WAS SEEN AGAIN ON (B)(6) 2013 AND THE DEVICE HAD BEEN TURNED OFF AT SOME POINT. IT WAS REPORTED THAT WHEN THE DEVICE WAS TURNED BACK ON, THE PATIENT HAD DIFFICULTY WITH SPEECH AND BALANCE AND THE PATIENT WAS REPROGRAMMED. IT WAS NOTED THAT STIMULATION WAS INCREASED ON THE LEFT SIDE AND DECREASED ON THE RIGHT SIDE, AND THE PATIENT WAS GETTING BETTER SYMPTOM CONTROL AFTER REPROGRAMMING. THE REPORTER STATED THAT THERE WAS NO MENTION OF SHOCKING SENSATION IN THE PATIENT'S CHART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319679 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| O