BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1803300 · Received August 17, 2010

    Report

    Report Number
    6000094-2010-01744
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    April 5, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE ON THE ATRIAL AND VENTRICULAR ELECTROGRAMS. LEAD FRACTURES WERE SUSPECTED. DURING THE REPLACEMENT PROCEDURE, THE NOISE DISAPPEARED WHEN THE LEADS WERE CONNECTED TO THE NEW DEVICE. SO THE LEADS WERE LEFT IN USE, AND THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention