BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2764185 · Received September 28, 2012

    Report

    Report Number
    3004209178-2012-08656
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 29, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3389S-40, LOT# V030207, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 3389S-40, LOT# V030207, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    A LOSS OF THERAPEUTIC EFFECT WAS REPORTED. IT WAS REPORTED THAT ON THE DATE OF THE EVENT, THE PATIENT PASSED THROUGH AIRPORT SECURITY AND IT WAS THOUGHT THAT "AIRPORT SECURITY MIGHT HAVE TURNED THE PATIENT'S IMPLANT OFF." STARTING THAT DAY, THE PATIENT HAD TREMORS THAT SHE DID NOT HAVE BEFORE. SHE WAS NOT ABLE TO WALK, SHE WAS ONLY ABLE TO CRAWL, AND SHE HAD CRAMPS IN HER TOES. IT WAS REPORTED THAT THE PATIENT HAD SEEN HER HEALTH CARE PROFESSIONAL (HCP) A MONTH EARLIER AND THE IMPLANTABLE NEURO STIMULATOR (INS) BATTERY WAS "FINE." THE PATIENT FORGOT TO BRING HER PATIENT PROGRAMMER ON HER TRAVELS AND REQUESTED ASSISTANCE WITH HER DEVICE. THREE DAYS AFTER THE DATE OF THE EVENT, THE PATIENT REPORTED SHE HAD MET WITH A MANUFACTURER REPRESENTATIVE WHO CHECKED THE INS AND MADE PROGRAMMING ADJUSTMENTS. IT WAS REPORTED THAT THE PATIENT WAS "DOING SIGNIFICANTLY BETTER."

    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 00073 YR