BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRA CRT-P

    MDR report key: 2791266 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02154
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    April 20, 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
    IN, 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 IMPLANT DETECT WAS STILL PROGRAMMED TO ON AND THERE WAS NO BATTERY OR OTHER DATA. THE ATRIAL LEAD IS IN PLACE AND ALL READINGS ARE WITHIN NORMAL RANGE. THE IMPLANT DETECT WAS TURNED OFF AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED 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 88 YR Required Intervention 4193 IMPLANTABLE PACING LEAD| 5554 IMPLANTABLE PACING LEAD| 5054 IMPLANTABLE PACING LEAD