BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 3857983 · Received June 9, 2014

    Report

    Report Number
    2182208-2014-01371
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    February 1, 2014
    Report Date
    March 26, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. MULTIPLE MANUFACTURES WERE REFERENCED IN THE ARTICLE. AN EMAIL WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AS OF YET. REFERENCED ARTICLE: PREDICTION OF MIDTERM PERFORMANCE OF ACTIVE-FIXATION LEADS USING CURRENT OF INJURY. PACE PACING AND CLINICAL ELECTROPHYSIOLOGY. 2014;37(2):231-236. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING MULTIPLE LEAD MODELS. MULTIPLE PATIENTS AND MULTIPLE FAILURE MODES WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. THE ARTICLE INCLUDED THE FOLLOWING FAILURE MODES: LEAD DISLODGEMENTS, SMALL ¿P¿ WAVES, HIGH THRESHOLDS, ATRIAL UNDERSENSING, AND INAPPROPRIATE SHOCKS. IT WAS NOTED THAT SOME OF THE LEADS REQUIRED INVASIVE INTERVENTION, HOWEVER, THE STATUS OF THE LEADS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335960 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R