BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 2790706 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05711
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS UNDERSENSING AND LOW BIPOLAR IMPEDANCE ON THE RIGHT VENTRICULAR LEAD. INSULATION FAILURE WAS SUSPECTED. IT WAS ALSO NOTED THAT THERE WAS POCKET STIMULATION AFTER CHANGING TO UNIPOLAR. IT WAS DETERMINED THAT VENTRICULAR CAPTURE MANAGEMENT WAS POSSIBLY THE ISSUE AND IT WAS TURNED OFF. THE SETTINGS WERE ADJUSTED AND THE DEVICE AND LEAD REMAIN IN USE. 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 SENSIA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 4068 IMPLANTABLE PACING LEAD