BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3864987 · Received June 10, 2014

    Report

    Report Number
    3002807561-2014-00009
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 19, 2012
    Report Date
    February 6, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: D354TRG ICD, (B)(6) 2012. A 0185 LEAD, (B)(6) 2009. A 53BP LEAD, (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POST IMPLANT, THE PATIENT DEVELOPED SEPSIS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEADS REMAINED IN USE. THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341210 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 00054 YR Hospitalization| R BS45D LEAD