BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2123449 · Received June 14, 2011

    Report

    Report Number
    6000144-2011-02272
    Event Type
    Injury
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4), THE DEVICE WAS RETURNED AND ANALYZED. THE ELECTIVE REPLACEMENT INDICATOR (ERI) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED THE ELECTIVE REPLACEMENT INDICATOR PREMATURELY. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 84 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| 4074 IMPLANTABLE PACING LEAD