BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENRHYTHM

    MDR report key: 2983332 · Received February 28, 2013

    Report

    Report Number
    9614453-2013-00538
    Event Type
    Death
    Date Received
    February 28, 2013
    Date of Event
    November 5, 2009
    Report Date
    February 7, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. NO FURTHER INFORMATION CAN BE OBTAINED FROM THE (B)(4) STUDY REGARDING THE PATIENT'S DEATH THAT WOULD/COULD DISASSOCIATE THE DEVICE SYSTEM AND EVENT. THEREFORE THIS EVENT WILL BE PROCESSED WITH THE INFORMATION AT HAND AND WILL BE CAPTURED AS A MEDICAL/DEATH ON INCOMING INFORMATION. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. (B)(4). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT, WHO WAS A PARTICIPANT IN THE (B)(4) STUDY, IS DECEASED. THE DEATH OCCURRED ONE YEAR AND SEVEN MONTHS POST IMPLANT. THE CAUSE OF DEATH IS UNKNOWN. THE ADVERSE EVENT COMMITTEE OF THE STUDY CLASSIFIED THE RELATEDNESS OF THE ADVERSE EVENT TO THE PROCEDURE OR DEVICE AS "UNKNOWN" AND THE DEATH HAS BEEN CLASSIFIED AS "UNKNOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86872 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Death