BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3153034 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05786
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. CONCOMITANT PRODUCTS: KSR703 IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN EXPECTED. THE DEVICE TRIGGERED ERI ONE MONTH AFTER THE PREVIOUS APPOINTMENT WHERE THE AVERAGE LONGEVITY ESTIMATE WAS 20 MONTHS. PROGRAMMING OF THE DEVICE WAS NOT POSSIBLE. IT WAS ALSO REPORTED THAT THERE HAD BEEN A GRADUAL INCREASE IN THRESHOLDS ON THE RIGHT VENTRICULAR (RV) LEAD AND RV THRESHOLDS AND OUTPUTS WERE HIGH. THE DEVICE WILL BE REPLACED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256147 ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO 4092

    Patients

    Seq Age Sex Outcome Treatment
    1