BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2738145 · Received September 10, 2012

    Report

    Report Number
    3004209178-2012-07955
    Event Type
    Malfunction
    Date Received
    September 10, 2012
    Report Date
    August 13, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 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), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID: 3387S-40, LOT#: V191279, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID: 3387S-40, LOT#: V191279, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND WEAKNESS. IT WAS "HARD TO EXPLAIN" FOR THE PATIENT, BUT SHE FELT THAT "SOMETHING LIKE HER PARKINSON'S [WAS] RETURNING." THE PATIENT FELT LIKE HER SYMPTOMS RETURNED AFTER RIDING ON HER STATIONARY BIKE UNTIL SHE WENT TO BED AT NIGHT; WHEN SHE AWOKE IN THE MORNING, HER SYMPTOMS WERE BETTER. THE PATIENT HAD NOT TYPICALLY CHECKED HER IMPLANTABLE NEUROSTIMULATOR (INS) WITH HER PATIENT PROGRAMMER (PP) AFTER BIKING; SHE CHECKED IT ONE TIME AND HER PROGRAMMER STATED HER INS WAS STILL ON. THE PATIENT WAS CONCERNED THAT HER BIKE PEDALS WERE MAGNETIC. SHE LAST EXPERIENCED THIS THE WEEK PREVIOUS. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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