BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z

    MDR report key: 3860463 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05423
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 28, 2013
    Report Date
    April 23, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ELEVATED THRESHOLD CHANGED TO "FAILURE TO CAPTURE - INTERMITTENT".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD ELEVATED THRESHOLDS WITH HIGH OUTPUT AND EXIT BLOCK. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT IS ENROLLED IN THE SYSTEM LONGEVITY STUDY (SLS). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341956 CAPSURE Z ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5033-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R