BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRA CRT-P

    MDR report key: 2810761 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02421
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P010015/S084
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THE PATIENT WENT TO THE HOSPITAL FEELING SYMPTOMATIC. THE PATIENT WAS NOTED TO HAVE HAD AN ATRIOVENTRICULAR NODE ABLATION AND NO ATRIAL LEAD WAS BEING USED. THE DEVICE WAS FOUND TO BE PACING INTO THE PREMATURE VENTRICULAR CONTRACTIONS. THE DEVICE WAS REPROGRAMMED AND IS STILL IN USE. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCRA CRT-P IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. C2TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| 6725 ADAPTOR