BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2203685 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04562
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND REVEALED THAT THE NO VENTRICULAR OUTPUT CONDITION WAS DUE TO AN ELECTRICAL DISCONTINUITY AT A SOLDER JOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD MEASURING ERRORS OF HIGH IMPEDANCE AND NO CAPTURE OF THE RIGHT VENTRICULAR LEAD, AS WHEN THE LEADS WERE TESTED WITH THE CABLES THEY HAD GREAT NUMBERS AND THRESHOLD BUT WHEN PLUGGED INTO THE DEVICE THERE WAS NO CAPTURE AND HIGH IMPEDANCE. THE DEVICE WAS REMOVED AND REPLACE. 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 MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD