BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2790818 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05613
    Event Type
    Injury
    Date Received
    October 15, 2012
    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
    IA, 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 AND ANALYZED. THERE WAS NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF A SHOCKING SENSATION IN THE UPPER CHEST AREA NEAR THEIR IMPLANTABLE PULSE GENERATOR (IPG). IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A HIGH NUMBER OF SHORT V-V INTERVALS. THE POCKET WAS OPENED TO FURTHER INVESTIGATE AND THE DEVICE AND PATIENT'S ARM WERE MANIPULATED IN AN ATTEMPT TO UNCOVER ANY LEAD ISSUES. NO NOISE WAS OBSERVED SO THE RV LEAD WAS LEFT IN PLACE AND THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER 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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| L| R 3830 IMPLANTABLE PACING LEAD