BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYNC III PACEMAKER

    MDR report key: 3071676 · Received April 22, 2013

    Report

    Report Number
    9614453-2013-01021
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    February 12, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    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 PRODUCTS: 4511 IMPLANTABLE PACING LEAD; 4011 IMPLANTABLE PACING LEAD; 4194 IMPLANTABLE PACING LEAD 2007 (B)(6). (B)(4).

    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 HEALTHCARE PROVIDER WANTED TO LOOK AT AN ATRIAL HIGH RATE (AHR) EPISODE AND THERE WAS NO TREND OR ELECTROGRAM (EGM) OF THE EPISODE IN THE IMPLANTABLE PULSE GENERATOR (IPG). THE DEVICE REMAIN 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
    171500 INSYNC III PACEMAKER PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP IPG MFG SWITZERLAND 8042B

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR