BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 3530804 · Received December 20, 2013

    Report

    Report Number
    3004209178-2013-23837
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Report Date
    December 4, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37601, SERIAL# (B)(4) IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387-40, LOT# L83935, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-51, SERIAL# (B)(4) IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION. PRODUCT ID: 64002, LOT# N355669, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ADAPTER. PRODUCT ID: 3389S-40, LOT# V006362, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V006362, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748266, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS AT 2.56 VOLTS AFTER ABOUT A YEAR OF USE. IT WAS STATED THAT THE PATIENT¿S DEVICE HAD SOME LOW IMPEDANCES ¿ WITH A VALUE OF 318 OHMS ¿ AND A POSSIBLE SHORT. IT WAS NOTED THAT THE PATIENT¿S DEVICE WAS PROGRAMMED WITH THE CASE AS POSITIVE, HAD TWO CATHODES, AN AMPLITUDE OF 4.0 VOLTS ON THE LEFT AND 2.5 VOLTS ON THE RIGHT, AND A RATE OF 175HZ. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD FALLEN, BUT DIDN¿T KNOW WHEN IT HAD HAPPENED; IT WAS THOUGHT TO HAVE HAPPENED AROUND (B)(6) 2013. IT WAS STATED THAT THE PATIENT FELT LIKE THE BATTERY HAD FLIPPED. ADDITIONALLY, IMPEDANCE TESTING WAS DONE AND THE RESULTS WERE THE FOLLOWING: LEFT SIDE SETTINGS: -1, -2, C+, 4.0V, 90US, 170HZ; LEFT SIDE RESULTS: 318OHMS, 11.693A; LEFT SIDE ELECTRODE IMPEDANCES: C0 ¿ 2530, C1 ¿ 454, C2 ¿ 548, C3 ¿ 1252, 01 ¿ 2331, 02 ¿ 2653, 03 ¿ 3231, 12 ¿ 619, 13 ¿ 1361, 23 ¿ 1242; RIGHT SIDE SETTING: -4, -6, C+, 3.5V, 90US, 170HZ; RIGHT SIDE RESULTS: 601OHMS, 5.682A; RIGHT SIDE ELECTRODE IMPEDANCES: C4 ¿ 1109, C5 ¿ 937, C6 ¿ 842, C7 ¿ 922, 45 ¿ 1154, 46 ¿ 1385, 47 ¿ 1549, 56 ¿ 1025, 57 ¿ 1314, 67 ¿ 1011; HISTORIC IMPEDANCES: (B)(6) 2012: LEFT SIDE: 258OHMS, 131A; RIGHT SIDE: 551OHMS, 59A; (B)(6) 2012: LEFT SIDE: 304OHMS, 1.3A; RIGHT SIDE: 551OHMS, 71A; (B)(6) 2013: LEFT SIDE: 296OHMS, 12.513A; RIGHT SIDE: 616OHMS, 5.551A; (B)(6) 2013: LEFT SIDE: 296OHMS, 11.176A; RIGHT SIDE: 623OHMS, 5.507A; (B)(6) 2013: LEFT SIDE: 340OHMS, 11.046A; RIGHT SIDE: 623OHMS, 5.595A. NO NEW INFORMATION. NO NEW INFORMATION. ADDITIONAL INFORMATION RECEIVED REPORTED LOW THERAPY IMPEDANCES AND ¿LOWER IMPEDANCES¿ ON C1 AND C2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668973 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR