BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXTRUS 4136

    MDR report key: 2980797 · Received February 19, 2013

    Report

    Report Number
    1028232-2013-00338
    Event Type
    Death
    Date Received
    February 19, 2013
    Date of Event
    December 12, 2012
    Report Date
    February 6, 2013
    Manufacturer
    BIOTRONIK SE & CO, KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE INITIAL IMPLANT PROCEDURE, RIGHT VENTRICULAR LOSS OF CAPTURE WAS NOTED WITH THIS LEAD. ANOTHER LEAD WAS IMPLANTED; HOWEVER, THE PT'S BLOOD PRESSURE AND HEART RATE WERE DROPPING AND THE PT WENT INTO CARDIAC ARREST. A PERFORATION WITH THIS LEAD WAS NOTED AND THE PHYSICIAN PERFORMED A STERNOTOMY AND STARTED CARDIAC MASSAGE. THE PT WAS STABILIZED AND THE CHEST WAS CLOSED. THE NEW LEAD EXHIBITED NORMAL DIAGNOSTICS JUST BEFORE LEAVING THE OPERATING ROOM AND REMAINED IMPLANTED. THE PT DID NOT REGAIN CONSCIOUSNESS AND EXPIRED SIX DAYS LATER. THE PHYSICIAN BELIEVES THE PERFORATION WAS DUE TO THE ELDERLY PT'S THIN MYOCARDIAL TISSUE. THE LEAD WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE HOSPITAL STAFF. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72358 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO, KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death