BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIA SR

    MDR report key: 2203761 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01630
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 3, 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 Location
    SW
    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 AND ANALYZED WITH NO ANOMALIES FOUND.

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW HOURS AFTER THE IMPLANT PROCEDURE, THE DEVICE EXHIBITED "EXIT BLOCK" AND WAS NOT CAPTURING. A LEAD DISLOCATION WAS SUSPECTED, HOWEVER WHEN THE PATIENT WAS TAKEN TO THE OPERATING ROOM, THE LEAD WAS WORKING APPROPRIATELY WITH THE ANALYZER. A FEW HOURS LATER, EXIT BLOCK OCCURRED AGAIN. X-RAYS AND THE LEAD ANALYZER CONFIRMED THE LEAD WAS WORKING APPROPRIATELY. AGAIN, A FEW HOURS LATER, EXIT BLOCK OCCURRED AGAIN. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND THE DEVICE WAS EXPLANTED AND REPLACED. THE NEW DEVICE WAS FUNCTIONING APPROPRIATELY DURING THE DEVICE CHECK THE FOLLOWING DAY. 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 SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. RESR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R