BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 3828737 · Received May 23, 2014

    Report

    Report Number
    3002807561-2014-00004
    Event Type
    Death
    Date Received
    May 23, 2014
    Date of Event
    February 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    EOC HEERLEN DISTRIBUTION CTR
    Product Code
    DTD
    PMA / PMN Number
    K982220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 4396 LEAD, IMPLANTED: (B)(6) 2012; SORIN ICD, IMPLANTED (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POCKET INFECTION OCCURRED. THE PATIENT WAS HOSPITALIZED AND A SURGICAL INTERVENTION WAS PLANNED TO EXPLANT THE LEADS AND COMPETITOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT DIED ONE DAY PRIOR TO THE PLANNED EXPLANT PROCEDURE. THE CAUSE OF DEATH WAS SEPTIC SHOCK. A SKIN SAMPLE AT THE DEVICE POCKET IDENTIFIED THE ORGANISM AS GOLDEN STAPHYLOCOCCUS METIS. THE PATIENT WAS ENROLLED IN A CLINICAL TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308092 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 00071 YR Death 693565 LEAD, 419478 LEAD, 1888TC ST JUDE LEAD