BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITY DDDR

    MDR report key: 2811041 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02350
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 7, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S4
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REPLACEMENT PROCEDURE, ELECTROCAUTERY INDUCED VENTRICULAR TACHYCARDIA WHICH DEGENERATED INTO VENTRICULAR FIBRILLATION BUT SPONTANEOUSLY CONVERTED TO SINUS RHYTHM ON THREE OCCASIONS. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARITY DDDR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. 860

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| O (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD