BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2613106 · Received June 12, 2012

    Report

    Report Number
    3004209178-2012-04329
    Event Type
    Injury
    Date Received
    June 12, 2012
    Report Date
    May 25, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT PRODUCT ID: 37 085-60 SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: EXTENSION, PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6). PRODUCT TYPE: EXTENSION, PRODUCT ID 3387S-40, LOT# V719607, IMPLANTED: (B)(6). PRODUCT TYPE: LEAD, PRODUCT ID: 3387S-40, LOT# V700663, IMPLANTED: (B)(6). PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REQUESTED REPORTED THAT THE PATIENT WAS STILL HAVING THERAPY ISSUES. THE PATIENT STATED THAT HER SYMPTOMS INCLUDED NUMBNESS IN HER LIPS, A SWELLING SENSATION OF HER TONGUE, BALANCE ISSUES AND DRAGGING OF HER RIGHT FOOT. THE PATIENT REPORTED HAVING SPEECH ISSUES DUE TO THE "STIMULATION BEING TURNED UP SO HIGH" IN (B)(6) 2011 AND THAT SHE HAD HER DEVICE REPROGRAMMED AT THE END OF THE MONTH. THE PATIENT ALSO STATED THAT THE ISSUES ASSOCIATED WITH THE DEVICE STARTED IN (B)(6) 2011 AND THAT THEY HAVE PROGRESSIVELY GOTTEN WORSE. THE PATIENT REPORTED HAVING HER STIMULATOR REPROGRAMMED IN (B)(6) 2011, AND (B)(6) 2012. THE PATIENT ALSO REPORTED HAVING HER STIMULATOR REPROGRAMMED ON (B)(6) 2012 AND SHE STARTED TO SHAKE AFTERWARDS. IT WAS FURTHER NOTED THAT THE PATIENT WAS REPROGRAMMED ON (B)(6) 2012 AND INITIALLY THE PATIENT FELT WELL, BUT SOON SHE REALIZED SHE COULDN'T HOLD A GLASS. THE PATIENT REPORTED NOT NOTICING ANY DIFFERENCE WHEN THE PHYSICIAN CHANGED HER MEDICATION A FEW DAYS LATER. THE PATIENT STATED THAT HER PHYSICIAN WAS REQUESTING A MRI AND THAT SHE NEEDED TO HAVE A MANUFACTURER REPRESENTATIVE PRESENT. THE PATIENT ALSO REPORTED THAT SHE FELL IN THE BATHROOM AND HIT THE BACK OF HER HEAD ABOUT A MONTH AND A HALF AGO. THE PATIENT STATED THAT SHE ALSO FELL OFF A FOOT STOOL AND "LANDED ON THE BED" ABOUT 3 WEEKS AGO. IT WAS FURTHER NOTED THAT THE PATIENT FELL WHILE LEANING FORWARD AND "KEPT GOING." THIS OCCURRED TWICE OVER A TWO WEEK SPAN. THE PATIENT STATED THAT HER KNEES HURT BECAUSE OF THE INCIDENT. THE PATIENT OUTCOME WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT THREE MONTHS FOLLOWING IMPLANT OF THE INTERNAL NEUROSTIMULATOR (INS) AND BILATERAL LEADS. MULTIPLE ATTEMPTS TO REPROGRAM THE LEADS WERE MADE WITHOUT IMPROVED RELIEF. THE PATIENT EXPERIENCED A CHANGE IN SPEECH SINCE IMPLANT AND REPORTED MY TONGUE FEELS LIKE IT IS BURNED." THE PATIENT WAS TOLD BY HER HEALTH CARE PROFESSIONAL TO TURN THE INS OFF AT NIGHT. THE PATIENT SAW A SECOND DOCTOR WHO NOTED "NOTHING TOO UNUSUAL, JUST SUB-OPTIMAL RESPONSE. THE ELECTRODE MAY NOT BE WELL PLACED." THE CAUSE OF THE EVENT MAY HAVE BEEN THE LEADS NOT PLACED AS WELL AS DESIRED. THE DOCTOR WAS WORKING ON REPROGRAMMING THE PATIENT WHICH RESULTED IN SOME IMPROVEMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention