BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELIA SR

    MDR report key: 3140029 · Received May 31, 2013

    Report

    Report Number
    3008973940-2013-00059
    Event Type
    Death
    Date Received
    May 31, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    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 PRODUCTS: 4965-35 IMPLANTABLE PACING LEAD, 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
    242356 RELIA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS RESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 DA Death