BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3211678 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08484
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    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 THAT THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD EXPERIENCED SYMPTOMS OF DIZZINESS. IN ADDITION, THEIR PULSE RATE WAS THIRTY BEATS PER MINUTE. THIS LEAD HAS CHRONIC INCREASED THRESHOLD MEASUREMENTS AND OUTPUT SETTINGS HAD BEEN PROGRAMMED TO [email protected]. THESE MEASUREMENTS HAD BEEN STABLE AND THERE WERE NO REPORTED SYMPTOMS. INTERROGATION REVEALED THRESHOLD MEASUREMENTS OF [email protected]. IN ADDITION, AN ELECTROGRAM REVEALED LOSS OF CAPTURE RESULTING IN THE LOW ESCAPE RHYTHM WHICH IN SOME CASES LASTED FOR FIVE SECOND INTERVALS. THE PATIENT WAS LIGHT-HEADED, BUT DID NOT EXPERIENCE SYNCOPE. AN URGENT LEAD REVISION IS INTENDED. UNTIL THE REVISION, OUTPUTS WERE INCREASED. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. IN ADDITION, THE DEVICE WAS ALSO REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308922 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R