BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E SERIES DR

    MDR report key: 2964457 · Received February 15, 2013

    Report

    Report Number
    9614453-2013-00428
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 4, 2012
    Report Date
    March 13, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4) - THE DEVICE WAS ANALYZED AND RETURNED AND NO ANOMALIES WERE FOUND. HOWEVER, THERE WAS GROMMET DAMAGE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEAD REVISION PROCEDURE, WHEN CONNECTING THE NEW LEAD TO THE DEVICE, A DEFECT IN THE CONNECTOR SITE WAS DISCOVERED. THE DEVICE WAS THEN EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67779 E SERIES DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE NVZ IPG MFG SWITZERLAND E60A1

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R