BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC.KAPPA

    MDR report key: 3152980 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01113
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    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. 4092 IMPLANTABLE PACING LEAD. (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
    256214 MEDTRONIC.KAPPA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND KSR703

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R