BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIA DR

    MDR report key: 2131553 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01168
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 19, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S097
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY FOR (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. ADDITIONAL FINDING OF THE SET SCREW HAVING FOREIGN MATERIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MEASURED HIGH VENTRICULAR IMPEDANCES WITH EXIT BLOCK SYMPTOMS. DURING THE REVISION IT WAS SEEN THAT THE SETSCREW WAS NOT FIXATED AND IT WAS NOT POSSIBLE TO FIXATE ANY LONGER. THE DEVICE WAS REMOVED 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
    1 RELIA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. REDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R