BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 2163395 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-08614
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 20, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING RECEIPT OF NEW INFORMATION, THIS CASE WILL BE FURTHER UPDATED AND A FOLLOW-UP REPORT SUBMITTED.

    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 THAT THE PATIENT WITH THIS DEVICE WAS HOSPITALIZED FOR A NON-CARDIAC ISSUE, WHEN INTERROGATION NOTED NOISE AND OVERSENSING ON THE ATRIAL AND SHOCK CHANNELS. NOISE HAD PRODUCED ATP; HOWEVER, NO REAL TIME NOISE PRESENT ON ELECTROGRAMS. THE DEVICE WAS THEN REPROGRAMMED TO VVI. BOSTON SCIENTIFIC'S INTERNAL TECHNICAL SERVICE CONSULTANTS, REVIEWED THE CASE AND NOTED OVER 3000 EPISODES HAD BEEN RECORDED OVER THE PAST (B)(6) AND OBSERVED A HIGH OUT OF RANGE SHOCK IMPEDANCE VALUE. IT WAS SUGGESTED TO INQUIRE WITH THE PATIENT TO SEE IF AN ELECTRICAL SOURCE CONTACT HAD BEEN INITIATED AROUND THE GENESIS DATE OF EPISODE STORAGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. FOLLOW-UP STATES THE PATIENT HAS NO RECOGNITION OF AN ELECTRICAL SOURCE CONTACT ON THAT DAY.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION COMMUNICATED THE PATIENT IN THIS CASE HAD SINCE EXPIRED. THE DEATH WAS REPORTED AS NOT DEVICE RELATED AND WITH NO ALLEGATIONS FROM THE MEDICAL FACILITY OR FAMILY. THE LOCATION OF THE DEVICE REMAINS UNKNOWN; HOWEVER, IT WAS REPORTED NO RETURN IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN GUIDANT PUERTO RICO BV 4096

    Patients

    Seq Age Sex Outcome Treatment
    1