BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2780092 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12278
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 15, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    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

    SUBSEQUENT INFORMATION INDICATES THAT THE PATIENT WAS SEEN FOR A LEAD REVISION PROCEDURE. THE LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LEAD IS TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE LEAD HAS BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD DISPLAYED A DECREASE IN SENSING AND A RISE IN PACING IMPEDANCE. LOSS OF MYOCARDIAL CAPTURE WAS ALSO OBSERVED. THE PATIENT UNDERWENT FLUOROSCOPY WHERE THE LEAD WAS DETERMINED TO HAVE DISLODGED. THE PATIENT WAS SCHEDULED FOR A LEAD REVISION PROCEDURE IN THE COMING WEEKS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. AS OF TODAY, THE LEAD REMAINS IN SERVICE.

    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 69 YR Life Threatening| R 4087| 0296| 5076| E162