BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2602362 · Received June 7, 2012

    Report

    Report Number
    3004209178-2012-04136
    Event Type
    Malfunction
    Date Received
    June 7, 2012
    Report Date
    May 9, 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

    PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3389S-40, LOT# V041062, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 3389S-40, LOT# V011992, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: INS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. A SHOCKING OR JOLTING SENSATION IN THE ARM AND CHEST AREA WAS ALSO REPORTED. TROUBLESHOOTING WAS PERFORMED. IMPEDANCES WERE LOW BUT WITHIN NORMAL LIMITS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS LAST SEEN BY A MANUFACTURE REPRESENTATIVE ON (B)(6) 2012 FOR A REPROGRAMMING SESSION. THE VOLTAGE WAS INCREASED AND THERAPY WAS REPORTEDLY "WORKING WELL." THE PATIENT'S TREMORS REPORTEDLY DECREASED AND HE DID NOT HAVE PROBLEMS WITH THE SHOCKING OR JOLTING SENSATION. IT WAS NOTED THAT THE PATIENT HAD BEEN REPROGRAMMED 4 OTHER TIMES WHERE THE MANUFACTURE REPRESENTATIVE'S ANALYSIS OF THE DEVICE FOUND THERE WAS NOTHING WRONG SINCE THE ORIGINAL CALL ON (B)(6) 2012. IT WAS FURTHER NOTED THAT THE PATIENT HAD SOME MENTAL HEALTH ISSUES FOR WHICH HE HAD BEEN HOSPITALIZED AND THE MANUFACTURE REPRESENTATIVE STATED THAT SHE BELIEVED THE SHOCKING AND JOLTING WERE CAUSE BY THE PATIENT'S "ALTERED MENTAL STATE" RATHER THAN THE DEVICE. IT WAS FURTHER REPORTED THAT AS OF (B)(6) 2012, THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AND HAD NO OTHER ISSUES. REFER TO MANUFACTURER REPORT #3004209178-2012-04138.

    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 37602

    Patients

    Seq Age Sex Outcome Treatment
    1