BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 1072659 · Received July 10, 2008

    Report

    Report Number
    2647346-2008-00367
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    February 21, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI
    Reporter Occupation
    INVALID DATA

    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: NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS EXPLANTED AND REPLACED DUE TO RAPIDLY REDUCED BATTERY VOLTAGE, SENSING DIFFICULTY, NO PACING OUTPUT, ATRIAL LEAD PACING THE VENTRICLE AND VENTRICULAR LEAD NOT CAPTURING THE VENTRICLE, AND HIGH THRESHOLD. A PROBLEM WITH THE CONNECTOR WAS SUSPECTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 4076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD