BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2865033 · Received December 10, 2012

    Report

    Report Number
    2647346-2012-01795
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 1, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CLINICIAN THAT A REMOTE MONITOR HAD A FAILED TRANSMISSION AND THE IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED A POSSIBLE RESET; THE SERIAL NUMBER DISPLAYED ALL ZEROS. THE DEVICE HAD A POP-UP RESET MESSAGE OCCUR DURING INTERROGATION. NO PARAMETERS REQUIRED A RESET. DEVICE AT SAME RATE AND MODE AS WHEN LAST SEEN. THE DEVICE REMAINS IN USE AS WELL AS THE REMOTE MONITOR, AS IT IS WORKING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention 4592 IMPLANTABLE PACING LEAD