BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2832956 · Received November 15, 2012

    Report

    Report Number
    3007566237-2012-02713
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    August 7, 2012
    Report Date
    October 17, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY EVENT: INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ALREADY DEPLETED AFTER ONLY 2 YEARS OF IMPLANT. THE PREVIOUS IMPLANTED INS LASTED 4 YEARS. PRELIMINARY GEO ASSESSMENT: ENCLOSED TROUBLE SHOOTING DATA EXCEL SHEET OF THE HOSPITAL SHOWED A LOW THERAPY IMPEDANCE ON BOTH SIDES (LEFT <(> <<)>(> <(><<)><(><<)>)>50 OHM; RIGHT 105 OHM) REQUESTED PRINT-OUTS PRELIMINARY GEO. CONCLUSION: NORMAL BATTERY DEPLETION SUSPECTED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) LASTED ONLY 2 YEARS AS THEIR PREVIOUS INS SYSTEM LASTED 4 YEARS. THE INS BATTERY VOLTAGE WAS REPORTED AS 2.48 VOLTS. INTERROGATION OF THE INS REVEALED THAT THE THERAPY IMPEDANCES WERE LOW ON BOTH THE LEFT (<(> <<)>50 OHMS AT 238 UA, BATTERY VOLTAGE AT 3.06 V) AND RIGHT SIDES (105 OHMS AT 281 UA, BATTERY VOLTAGE AT 3.06 V) OF THE PATIENT. IT WAS NOTED THAT THE PATIENT DID EXPERIENCE DECREASED THERAPY DUE TO THE LOW BATTERY EVENT. THE PATIENT WAS REPROGRAMMED AND SCHEDULED FOR REPLACEMENT PROCEDURE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention