BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 2866062 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-18041
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    September 13, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (B)(4) IMPLANTABLE PULSE GENERATOR 2004-(B)(6), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH THRESHOLD. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 5071 IMPLANTABLE PACING LEAD