BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 3943475 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13216
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    July 2, 2014
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7428, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7428, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7436, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# J0546531V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# V000525, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ALL IMPEDANCES AND DIAGNOSTICS SHOWED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS WORKING FINE. THE ¿JOLT/PARASTHESIAS¿ WERE A ONE-TIME THING AND THE DOCTOR HAD DONE EXHAUSTIVE PROGRAMMING ATTEMPTS TO TRY TO HELP THE PATIENT. THE PATIENT ALSO CONSULTED WITH HIS NEUROSURGEON, WHO DID NOT SEEM INTERESTED IN DOING ANYTHING SURGICALLY TO TRY TO FIX AN INS THAT WAS WORKING AS IT SHOULD.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD ALWAYS FELT A JOLT OR MOMENTARY PARESTHESIA SENSATION WHEN THEY TURNED THEIR STIMULATION ON BUT THEY ALSO REPORTED FEELING THAT WHEN THE STIMULATION WAS TURNED OFF. IT HAD STARTED WHEN THE INS WAS REPLACED. WHEN THE LEFT INS WAS TURNED OFF, THEY STILL WOULD GET BENEFIT ON THE RIGHT SIDE OF THEIR BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422245 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR