BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3904581 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09546
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 12, 2014
    Report Date
    May 19, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOWING PRODUCT RETURN AND COMPLETION OF LAB ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LEAD HAS BEEN RETURNED. BOSTON SCIENTIFIC HAS CONCLUDED IT IS UNLIKELY THAT LEAD CHARACTERISTICS CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. 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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT APPROXIMATELY A FEW MONTHS POST-IMPLANT, THIS RIGHT VENTRICULAR AND RIGHT ATRIAL LEAD DISLODGED. THE PATIENT WAS REPORTED SYNCOPAL AND SOUGHT MEDICAL ATTENTION, AT WHICH TIME AN X-RAY CONFIRMED THE DISLODGED LEADS. SURGICAL INTERVENTION WAS PLANNED AND PERFORMED A FEW DAYS LATER; BOTH RV AND RA LEADS WERE EXPLANTED AND REPLACED. EXPLANTED LEADS ARE INTENDED TO BE RETURNED FOR ANALYSIS. NO FURTHER RESULTING ADVERSE PATIENT EFFECTS OF NOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382453 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4087| 4088| S209