BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III

    MDR report key: 3862468 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01379
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 3, 2013
    Report Date
    April 28, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    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 MEDICAL PRODUCTS: A 419388 LEAD IMPLANTED: (B)(6) 2002. A 456845 LEAD IMPLANTED: (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PREVIOUS DEVICE HAD MIGRATED FROM IT'S ORIGINAL POSITION AND WAS SLIGHTLY PROTRUDING FROM THE PATIENT'S CHEST CAUSING THE PATIENT DISCOMFORT. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339352 INSYNC III PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP IPG MFG SWITZERLAND 8042B

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R 507658 LEAD