BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3143028 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08553
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    August 30, 2012
    Report Date
    May 14, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387-40 LOT# J0443929V, IMPLANTED: 2006 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3387-40 LOT# J0443929V, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 7436 LOT# SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3387-40 LOT# J0443929V, IMPLANTED: 2006 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE THERAPY THE DEVICE WAS USED FOR WAS EPILEPSY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED A MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS PERFORMED THE DAY OF SURGERY AND SHOWED THE NEW RIGHT LEAD WAS IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE RIGHT LEAD HAD HIGH IMPEDANCE. IT WAS NOTED, THERE WAS A RIGHT LEAD FRACTURE RELATED TO IMPLANTED SYSTEM. NO ACTIONS HAD BEEN TAKEN AND IT WAS NOTED AS AN ONGOING EVENT. IT WAS LATER REPORTED THE LEAD WAS REPLACED ON (B)(6) 2013. IT WAS NOTED AN X-RAY AND MRI WERE DONE. THE PATIENT RESOLVED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244101 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention