BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2854745 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11074
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 37642 LOT# SERIAL# (B)(4),: PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37092 LOT# 279290001, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3389S-40 LOT# V621021, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT ¿FELL ON HER PROGRAMMER¿ AND SHE WAS SEEING ¿SOME WEIRD NUMBERS COMING UP.¿ THE PATIENT PROGRAMMER WAS SHOWING THAT THE BATTERY WAS 35%. IT WAS NOTED THAT THE PATIENT FELL A WEEK OR A COUPLE OF DAYS PRIOR TO THE DATE OF THIS REPORT AND SHE FELL ON THE LEFT SIDE OF HER CHEST WHICH WAS WHERE THE STIMULATOR WAS. IT WAS NOTED THAT THE IMPEDANCES READINGS WERE LESS THAN 3200 WHEN THE DEVICE WAS CHECKED IN (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY MEASUREMENT ON THE PATIENT PROGRAMMER WAS 35%. THE PATIENT'S VOLTAGE WAS LOW AND ESTIMATED TO BE 1.7 VOLTS, BUT IT WAS INCREASED TO 1.9 VOLTS. THE LONGEVITY WAS "APPROXIMATELY" SEVEN YEARS BASED ON THE PATIENT'S SETTINGS AND THUS THE BATTERY MEASUREMENT SEEMED "INAPPROPRIATE" FOR THE DURATION OF THE IMPLANT. THE PATIENT WAS ABLE TO CHANGE HER SETTINGS AND HAS NOT HAD THE SYSTEM "CHECKED" SINCE OCTOBER 2011. IT WAS ALSO REPORTED THAT THE PATIENT "FELL" A FEW DAYS OR POSSIBLY A WEEK PRIOR TO THE REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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