BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRA CRT-P

    MDR report key: 2811310 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02379
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    June 4, 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
    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 THE DEVICE INTERROGATION HAD NO DIAGNOSTICS. THE IMPLANT DETECTION WOULD NOT COMPLETE BECAUSE THE ATRIAL PORT WAS PLUGGED. THE IMPLANT DETECT WAS MANUALLY TURNED OFF. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN 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 76 YR Required Intervention 4193 IMPLANTABLE PACING LEAD| 5076 X2 IMPLANTABLE PACING LEAD