BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2952203 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01686
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. CONCOMITANT PRODUCT: 1388T, COMPETITOR IMPLANTABLE PACING LEAD, (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LOST TELEMETRY AS THE TRANSMISSION SHOWED FREQUENT VERTICAL DASHED LINES ON NON-MAGNET AND MAGNET. IT WAS NOTED THAT THE AMPLITUDE OF VP (VENTRICULAR PACE) IS SMALLER ON THE NON-MAGNET. FOLLOW-UP WAS CONDUCTED AND FROM THE INFORMATION OBTAINED IT WAS REPORTED THAT THE "LOW AMPLITUDE" CONDITION WAS THE CAUSE OF THE EVENT AND THAT THERE WAS NO REPROGRAMMING OF THE DEVICE. 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
    57567 N/A PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR (B)(4) IMPLANTABLE PACING LEAD