BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIA SR

    MDR report key: 3182198 · Received June 21, 2013

    Report

    Report Number
    9614453-2013-01443
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    July 26, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    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

    PRODUCT EVENT SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

    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. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED AND NOT RECEIVED AND WILL BE ADDED TO THE EVENT AND PROCESSED APPROPRIATELY IF RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). INTERROGATION OF THE DEVICE REVEALED A HISTORY OF HIGH THRESHOLD AND MAXIMUM OUTPUT PROGRAMMED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283255 RELIA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND RESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 YR Hospitalization| R