BEUDAMED
    FDA Adverse Event Death Summary report: N

    FINELINE II

    MDR report key: 2950990 · Received February 8, 2013

    Report

    Report Number
    2124215-2013-02787
    Event Type
    Death
    Date Received
    February 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN OUT-OF-SERVICE FORM THAT THIS PATIENT HAD BEEN PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOR A SCHEDULED SYSTEM EXTRACTION DUE TO INFECTION. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT DIED FOLLOWING THE PROCEDURE WHILE IN THE HOSPITAL'S INTENSIVE CARE UNIT (ICU). ACCORDING TO THE PHYSICIAN, THE INFECTION WAS NOT DEVICE-RELATED, HOWEVER, THE EXTRACTION OF THE LEADS MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE CAUSE OF DEATH WAS DOCUMENTED AS MYOCARDIAL INFARCTION (MI). SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LOCAL REPRESENTATIVE SPOKE DIRECTLY WITH THE PHYSICIAN. A REVIEW OF THE OPERATIVE REPORT NOTED THAT DURING POCKET CLOSURE, THE PATIENT DEVELOPED INFERIOR ST ELEVATIONS AND SUPERIOR/ANTERIOR/LATERAL ST DEPRESSION ASSOCIATED WITH A DROP IN BLOOD PRESSURE. HEMODYNAMIC STABILIZATION WAS ACHIEVED FOLLOWING ADMINISTRATION OF NORMAL SALINE SOLUTION (NSS) AND NEO-SYNEPHRINE. THE BLOOD PRESSURE STABILIZED BUT AFTER 2-3 MINUTES, LOW BLOOD PRESSURE WAS AGAIN ENCOUNTERED. THE PATIENT WAS STARTED ON EPINEPHRINE, DOPAMINE, LEVOPHED AND DOBUTREX. THE PATIENT WAS INTUBATED AND FEMORAL VENOUS/ARTERIAL ACCESS WAS OBTAINED. A TEMPORARY PACING WIRE WAS INSERTED. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE ICU. UNFORTUNATELY, THE PATIENT DIED SHORTLY UPON ARRIVAL TO THE ICU. THE ROOT CAUSE OF THE INFECTION REMAINS UNCERTAIN BUT THE PHYSICIAN SUSPECTS THAT THE INFECTION OCCURRED SOMETIME AFTER THE PACEMAKER REPLACEMENT IN (B)(6) 2010. THERE WAS NO IDENTIFIED VEGETATION ON THE IMPLANTED LEADS. BLOOD CULTURES WERE OBTAINED FROM THE POCKET SITE, HOWEVER, THE RESULTS ARE UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54567 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H| L| R 1280| 4039| S603| 4457