BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC

    MDR report key: 4162944 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-03040
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 4, 2014
    Report Date
    August 8, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCTS: PRODUCT ID 5076-45, LEAD, IMPLANTED: (B)(6) 2006; 5076-52, LEAD, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S MEDICAL HISTORY INDICATED THAT THE PATIENT HAD UNDERGONE A COMPUTERIZED TOMOGRAPHY (CT) SCAN. DURING A DEVICE CHECK THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED THAT A POWER ON RESET (POR) HAD OCCURRED. THE RESET WAS CONSIDERED TO HAVE BEEN TRIGGERED BY THE EFFECT OF THE CT SCAN. ADJUSTMENTS OF THE IPG PROGRAM SETTINGS WERE MADE AND THE DEVICE REMAINS IN USE. ADDITIONALLY, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED NO PACING DUE TO DISLODGEMENT. THE LV LEAD WAS ABANDONED AND REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639032 INSYNC PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 8040

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R 419378 LEAD