BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXTEND

    MDR report key: 2875262 · Received December 17, 2012

    Report

    Report Number
    2124215-2012-16765
    Event Type
    Death
    Date Received
    December 17, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 18, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LOCAL REPRESENTATIVE SPOKE DIRECTLY WITH THE PHYSICIAN. ACCORDING TO THE PHYSICIAN, THE EXTRACTION PROCEDURE ASSOCIATED WITH THE TEAR OF THE SUPERIOR VENA CAVA (SVC) DID CONTRIBUTE TO THE PATIENT'S DEATH. THE DOCUMENTED CAUSE OF DEATH WAS RELATED TO REFRACTORY ACIDOSIS. THE REPORTED INFECTION DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOR EXTRACTION OF THIS PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND TRANSVENOUS LEAD SYSTEM DUE TO INFECTION. THE PATIENT PAST IMPLANT HISTORY IS SIGNIFICANT FOR A RECENT SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) IN PREPARATION FOR THE EXTRACTION PROCEDURE. DURING THE EXTRACTION PROCEDURE, THE SUPERIOR VENA CAVA (SVC) WAS TORN. THE SVC WAS REPAIRED AND THE ENTIRE SYSTEM WAS SUCCESSFULLY EXTRACTED. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PHYSICIAN CONTACTED THE LOCAL REPRESENTATIVE TO REPORT THAT THIS PATIENT HAD DIED FOUR DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death 0185| 0184| T165| 4086