BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCRA CRT-P

    MDR report key: 2203697 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01539
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 19, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P010015/S084
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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'S DEVICE IS NOT SHOWING DIAGNOSTIC INFORMATION. DIAGNOSTICS WERE ADJUSTED. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other 5076 IMPLANTABLE PACING LEAD| GCIII SOFTWARE| 4196 IMPLANTABLE PACING LEAD