BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2864997 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11451
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    April 2, 2012
    Report Date
    October 9, 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
    MN, 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. CONCOMITANT PRODUCT: 5568 IMPLANTABLE PACING LEAD 2003 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SENT A REMOTE TRANSMISSION SHOWING THE PATIENT GOING IN AND OUT OF MODE SWITCH. THERE WAS LOSS OF TELEMETRY MARKERS POSSIBLY DUE TO UNDERSENSING. IT WAS SUGGESTED THAT THE PATIENT BE BROUGHT IN TO ADJUST SENSITIVITY. 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
    1 N/A PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR 5068 IMPLANTABLE PACING LEAD