BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENRHYTHM

    MDR report key: 2964560 · Received February 15, 2013

    Report

    Report Number
    9614453-2013-00504
    Event Type
    Death
    Date Received
    February 15, 2013
    Date of Event
    October 21, 2009
    Report Date
    January 16, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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 U.S. 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). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. 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 A PATIENT IS DECEASED AND DIED ON (B)(6) 2009; APPROXIMATELY TWO YEARS POST THE IMPLANT ((B)(6) 2007) OF AN IPG. THE PATIENT WAS A PARTICIPANT IN THE (B)(4) STUDY AND DIED "OUT OF HOSPITAL"; THEREFORE, NO FURTHER INFORMATION WILL BE PROVIDED REGARDING THE PATIENT'S DEATH. THE PHYSICIAN-INVESTIGATOR CLASSIFIED THE DEATH AS "UNKNOWN" AND HAD NO COMPLAINT. IT WAS PREVIOUSLY REPORTED THAT A YEAR PRIOR TO THE DEATH THE ATRIAL LEAD HAD HIGH CAPTURE THRESHOLD. AFTER DEVICE REPROGRAMMING THE CAPTURE THRESHOLD WAS LOWER AND THE LEAD REMAINED IN USE. AT THE TIME OF THE DEATH BOTH THE DEVICE AND ATRIAL LEAD WERE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68665 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Death 4574 IMPLANTABLE PACING LEAD