BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCRA CRT-P

    MDR report key: 2955503 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00278
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A NON-CLEARABLE ATRIAL LEAD WARNING. THE CALLER NOTED THAT THERE IS NOT AN ATRIAL LEAD ATTACHED TO THE DEVICE AND WOULD LIKE THE ATRIAL LEAD WARNINGS TO STOP. THE CALLER WAS ADVISED THAT UNFORTUNATELY THE WARNINGS WOULD NOT STOP SINCE THERE IS NOT AN ATRIAL LEAD. IT WAS ALSO REPORTED THAT THE LONGEVITY ESTIMATE SEEMED TO BE INCORRECT AS IT WAS SHOWING ONLY THREE TO FOUR YEARS LEFT. IT WAS NOTED THAT THE UPDATED SOFTWARE WAS NOT AVAILABLE. 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
    59383 SYNCRA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C2TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR (B)(4) IMPLANTABLE PACING LEAD