BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3011447 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03934
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 28, 2013
    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
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387-40, LOT# V004552, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 3387-40, LOT# V004552, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEUROSTIMULATOR, SERIAL #(B)(4), FOUND THE BATTERY AT NORMAL END OF LIFE AND THE TELEMETRY AND OUTPUT OKAY. THERE WAS NO SIGNIFICANT ANOMALY. THE PARAMETERS WERE TAKEN FROM THE INS AND THE LONGEVITY ESTIMATE WAS 30 MONTHS; IT WAS IMPLANTED FOR 40.7 MONTHS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALLER HAD A LOSS OF THERAPEUTIC EFFECT DUE TO SUSPECTED ELECTROMAGNETIC INTERFERENCE (EMI). IT WAS STATED THAT THE PATIENT'S DEVICE WAS TURNED OFF FROM 2011 TO (B)(6) 2013 AND THE PATIENT FELL "LESS TIMES" WHEN THE DEVICE WAS OFF THAN WHEN IT WAS ON. IT WAS STATED THAT WHEN THE PATIENT WAS IN THE KITCHEN AND BATHROOM, OR WALKING OUTSIDE BY POWER LINES/UNDERGROUND WIRES, HER SYMPTOMS WOULD RETURN. THE CALLER STATED SHE THOUGHT THE SYMPTOMS BEGAN AFTER THEY GOT A DIGITAL TV IN THE BEDROOM. REPORTEDLY THE REPRESENTATIVE TURNED OFF THE REED SWITCH AND THE DEVICE WAS WORKING PROPERLY, HOWEVER THE PATIENT WAS STILL HAVING "EPISODES." IT WAS NOTED THAT THE PATIENT STATED SHE LIKED IT WHEN SHE LEFT HER HOUSE, SHE FELT "SO MUCH BETTER." ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE PATIENT GOT INTO A CAR ACCIDENT AND LOST QUITE A BIT OF WEIGHT. IT WAS UNKNOWN IF THE WEIGHT LOSS WAS DUE TO THE CAR ACCIDENT OR THE IMPLANTABLE PULSE GENERATOR. IT WAS NOTED THAT WHEN THE PATIENT¿S SYMPTOMS RETURNED THE PATIENT WOULD ARCH HER BACK AND WAS REALLY UNCOMFORTABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNING ON AND OFF. IT WAS NOTED THAT WHEN THE INS WAS ON THE PATIENT COULD NOT MOVE AND WAS STIFF.

    Description of Event or Problem · 1

    FURTHER INFORMATION RECEIVED REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114260 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention