BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1953540 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23909
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    February 26, 2010
    Report Date
    January 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, THIS LEAD WAS REMOVED FROM SERVICE WITH EVIDENCE OF FRACTURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION, BEYOND THE EARLY SURGICAL INTERVENTION. THIS MEDICAL DEVICE HAS BEEN RETURNED TO BOSTON SCIENTIFIC BUT ANALYSIS REMAINS INCONCLUSIVE TO DATE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED. THE INVESTIGATION REMAINS OPEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS RA LEAD WAS TO BE REMOVED FROM SERVICE. THE INVESTIGATION IS CONSIDERED CLOSED AT THIS TIME. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT ATRIAL (RA) LEAD WAS TO BE REMOVED FROM SERVICE AS A RESULT OF NOISE PRESENT AND GREATER THAN 3,000 OHMS PACE IMPEDANCE MEASUREMENT. THERE HAD BEEN NO REPORTED PATIENT SYMPTOM ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention 0185| T180| 4087| T167