BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2592229 · Received May 30, 2012

    Report

    Report Number
    3004209178-2012-03820
    Event Type
    Malfunction
    Date Received
    May 30, 2012
    Date of Event
    April 28, 2012
    Report Date
    May 1, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION, PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION: PRODUCT ID: 7436, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER: PATIENT PRODUCT ID 3387S-40, LOT# V291949, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V273701 IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD. (B)(4). MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION.

    Description of Event or Problem · 1

    HOLD FOR IRENE 10-02-12IT WAS REPORTED THAT THE STIMULATION COULD NOT BE ADJUSTED. WHEN THE PATIENT INCREASED/DECREASED STIMULATION, HE ONLY HEARD THREE BEEPS. WHEN THE IMPLANTABLE NEUROSTIMULATOR WAS TURNED ON, THE BATTERY LIGHT DID NOT ILLUMINATE. THE PATIENT LOST THERAPEUTIC EFFECT ON (B)(6) 2012. THE PATIENT'S LAST APPOINTMENT WAS ELEVEN MONTHS AGO AND HAD AN APPOINTMENT SCHEDULED ONE WEEK FROM THE DATE OF THE REPORT. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE LOSS OF EFFECT. REPROGRAMMING OF STIMULATION WAS REVIEWED TO ADDRESS STIMULATION NEEDS DUE TO POWER ON RESET, OR A POTENTIALLY DEPLETED INS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECEIVED ASSISTANCE FROM THE PHYSICIAN OR MANUFACTURER REPRESENTATIVE ON (B)(6) 2012 AND THE ISSUE WAS RESOLVED. PATIENT OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR