BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2719325 · Received August 29, 2012

    Report

    Report Number
    3004209178-2012-07509
    Event Type
    Injury
    Date Received
    August 29, 2012
    Report Date
    August 6, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, LOT#, SERIAL# UNKNOWN, IMPLANTED: 2003 (B)(6), EXPLANTED: PRODUCT TYPE LEAD, PRODUCT ID NEU_UNKNOWN_EXT, LOT#, SERIAL# UNKNOWN, IMPLANTED: 2003 (B)(6), EXPLANTED: PRODUCT TYPE EXTENSION, PRODUCT ID 7438, LOT#, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WOULD GET A SHOCKING OR JOLTING SENSATION SOMETIMES. THE PATIENT WAS HAVING THE BATTERY REPLACED TODAY AS DEVICE INTERROGATION FOUND THE BATTERY TO BE EOL (END OF LIFE) WITH A BATTERY MEASUREMENT OF 2.05V. DURING THE PROCEDURE THE PHYSICIAN NOTICED THAT THE EXTENSION HAD 3 FRAYED WIRES JUST DISTAL OF THE 'DUCKHEAD' AND ONLY 1 WIRE APPEARED TO BE INTACT. IN SPITE OF THIS, THE PATIENT WAS PREVIOUSLY GETTING EXCELLENT THERAPY AND WAS PROGRAMMED MONOPOLOR, C+,1-. THE USE PARAMETERS FOR THE DEVICE WERE 4.5V, 120 US, 160 HZ, Z=300, AND 16 MONTHS FROM DOI. IT WAS ALSO REPORTED THAT THE THERAPY IMPEDANCE WAS 300 OHMS, WHICH WAS A VERY LOW VALUE FOR THE DEVICE PROGRAM. A SURGICAL REVISION WAS GOING TO BE DONE TO REPLACE THE EXTENSION. SUBSEQUENT INFORMATION RECEIVED REPORTED THAT NOTHING DEFINITIVE WAS DETERMINED AS TO THE CAUSE OF THE WIRE FRACTURE. THE PATIENT SEEMED FINE AND WAS CONTINUING TO GO IN FOR PROGRAMMING TITRATION WITH NEW BATTERY. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 Required Intervention