BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELIA D

    MDR report key: 3869054 · Received June 12, 2014

    Report

    Report Number
    9614453-2014-01509
    Event Type
    Death
    Date Received
    June 12, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED AND DIED POST IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. IT WAS FURTHER REPORTED THAT THE PATIENT LOST CONSCIOUSNESS AFTER SUTURING THE POCKET. THE PATIENT HAD COMPLAINED OF FEELING A ¿PALPITATION¿ DURING SUTURE REMOVAL PRIOR TO LOSING CONSCIOUSNESS. THE PATIENT BECAME BREATHLESS AND ASYSTOLIC. RESUSCITATION EFFORTS WERE INITIATED BUT WERE UNSUCCESSFUL. ADDITIONAL INFORMATION NOTED THAT EVERY TEST PARAMETER WAS WITHIN NORMAL LIMITS. AN ECHOCARDIOGRAM WAS PERFORMED AND COULD NOT EXCLUDE THE POSSIBILITY OF HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY. AN XRAY WAS PERFORMED AND NO PERFORATION, LEAD DISPLACEMENT OR PNEUMOTHORAX WAS PRESENT BUT COULD NOT EXCLUDE THE POSSIBILITY OF PULMONARY EDEMA. A CEREBRAL COMPUTERIZED TOMOGRAPHY SCAN WAS COMPLETE AND NO CEREBRAL HEMORRHAGE WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346966 RELIA D PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND RED01

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Death 5076-58 LEAD, 4574-53 LEAD