BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE EPI

    MDR report key: 3140083 · Received May 31, 2013

    Report

    Report Number
    2649622-2013-05466
    Event Type
    Death
    Date Received
    May 31, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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). CONCOMITANT PRODUCT: RESR01 IMPLANTABLE PULSE GENERATOR (IPG), IMPLANTED: (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DECEASED. THE PATIENT IS REPORTED TO HAVE HAD A POCKET INFECTION AND DURING REVISION PROCEDURE, THE PATIENT COLLAPSED AND DIED. THE PHYSICIAN NOTED ¿PACEMAKER MALFUNCTION¿ IN THE DEATH CERTIFICATE. ADDITIONAL INFORMATION RELATED TO THE DEVICE MALFUNCTION AND CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242089 CAPSURE EPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4965-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 DA Death