BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2951855 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01636
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 12, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANTS: 5076-45 IMPLANTABLE PACING LEAD 2012 (B)(6). 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 BY THE CALLER THAT THERE WAS LOSS OF TELEMETRY. THE KEY POINTS OF THE KNOWN ISSUE WERE DISCUSSED. 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
    56585 N/A PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR 4074-52 IMPLANTABLE PACING LEAD