BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE

    MDR report key: 4970930 · Received August 5, 2015

    Report

    Report Number
    2647346-2015-00030
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 22, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    NVZ
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) HAD NO FUNCTION WHEN A MAGNET WAS PLACED OVER IT. THE IPG WAS EXPLANTED AND REPLACED WITH A SINGLE CHAMBER DEVICE. IT WAS ALSO REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLDS WHEN PROGRAMMED BIPOLAR AND LOWER VALUES IN UNIPOLAR. THE RA LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD NO CAPTURE, HIGH IMPEDANCE, AND A POSSIBLE FRACTURE. THE RV LEAD WAS CAPPED BUT NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513489 ELITE PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MDT PUERTO RICO OPERATIONS CO, MED REL 7076

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R