BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ C SERIES DR

    MDR report key: 2130447 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01077
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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. THE EXACT CAUSE OF THE HIGH CURRENT DRAIN COULD NOT BE CONFIRMED AS THE DEVICE FAILURE DISAPPEARED DURING ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED END OF LIFE (EOL) SUDDENLY. AN ERROR CODE WAS NOTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED END OF LIFE (EOL) SUDDENLY. 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
    1 DA+ C SERIES DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. C60A3 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 5568 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD