BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWO IS-1 BI LEADS TO IS-1 BI IPG ADAPTOR KIT

    MDR report key: 3864992 · Received June 10, 2014

    Report

    Report Number
    3002807561-2014-00010
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    July 24, 2012
    Report Date
    January 31, 2013
    Manufacturer
    EOC HEERLEN DISTRIBUTION CTR
    Product Code
    DTD
    PMA / PMN Number
    K982220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: 419688 LEAD, IMPLANTED: (B)(6) 2011; PRODUCT ID: 429678 LEAD, IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFECTION. THE SYSTEM WAS EXPLANTED. THE PATIENT IS A PARTICIPANT IN THE (B)(6) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339128 TWO IS-1 BI LEADS TO IS-1 BI IPG ADAPTOR KIT ADAPTOR, LEAD, PACEMAKER DTD EOC HEERLEN DISTRIBUTION CTR 2872

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| R D234TRK CRT-D