BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCRA CRT-P

    MDR report key: 2955384 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00293
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 AT A DEVICE CHECK APPROXIMATELY ONE MONTH POST IMPLANT THAT THE DEVICE LONGEVITY WAS ESTIMATED TO BE ONLY TWO YEARS REMAINING. THE DEVICE IS STILL 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
    58738 SYNCRA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C2TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR 4196 IMPLANTABLE PACING LEAD