BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIA DR

    MDR report key: 2810612 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02417
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    August 10, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S097
    Removal / Correction Number
    Z-2120-2011
    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: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. PERFORMANCE DATA WAS COLLECTED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN DISCONNECTED THE LEAD FROM THE DEVICE DUE TO A SURGICAL MANEUVER. WHEN TRYING TO RECONNECT THE LEADS TO THE HEADER, THE LEADS NO LONGER FIT IN THE HEADER. THE DEVICE WAS NOT USED AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other