BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151753 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05633
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    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. PRODUCT ID: 693165, IMPLANTABLE TACHY LEAD, (B)(6) 2005. PRODUCT ID: D354TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).  (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS SUDDENLY HIGH IMPEDANCE ON THE RIGHT VENTRICULAR (RV) SHOCK COIL. IT WAS ALSO REPORTED THAT THERE WAS HIGH IMPEDANCE AND HIGH THRESHOLD ON THE LEFT VENTRICULAR (LV) LEAD. THE RV LEAD WAS CAPPED AND REPLACED. PROGRAMMING CHANGES WERE MADE AND THE LV 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
    252416 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R