BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2868335 · Received December 11, 2012

    Report

    Report Number
    3007566237-2012-02982
    Event Type
    Injury
    Date Received
    December 11, 2012
    Report Date
    November 20, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V022878, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V021585, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION FOR HIS DEEP BRAIN STIMULATOR (DBS). IT WAS UNKNOWN IF THE REVISION WAS ON DEVICE OR AN OTHER CONTAMINANT PRODUCT. THE DATE, CAUSE OF THE EVENT, AND PATIENT OUTCOME WERE UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REVISION WAS A LEAD REVISION AND 'NOTHING WAS REALLY WRONG WITH THE LEADS.' THE REPORTER STATED THAT THERE WERE 'SOME IMPEDANCES.' IT WAS UNCLEAR WHAT THIS REFERRED TO. IT WAS REPORTED THAT THE PROCEDURE WAS DONE 'AT THE INSISTENCE OF THE PATIENT' BECAUSE HE WAS NOT HAPPY WITH THE RESULTS OF THE THERAPY AND THE EFFICACY. THE REPORTER STATED THAT THE PATIENT TOLERATED THE LEAD REPLACEMENT FINE AND WAS HAPPIER AFTER THE REVISION.

    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 00062 YR Required Intervention