BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIA DR

    MDR report key: 3861146 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01468
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 THAT THE PATIENT HAD FAINTED SEVERAL TIMES DURING THE MONTH. TELEMETRY REVEALED EXIT BLOCK AND PACING RATES BELOW THE LOWEST RATE. IT WAS NOT POSSIBLE TO DETERMINE IF THE PROBLEM WAS RELATED TO THE IMPLANTABLE PULSE GENERATOR (IPG) OR THE RIGHT VENTRICULAR (RV) LEAD. THE SENSING AND THRESHOLDS ON THE RV LEAD WERE IN RANGE. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEAD WAS CAPPED AND REPLACED. THE PACEMAKER SYSTEM WAS REPLACED WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341671 RELIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND REDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 407658