BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3790181 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-04478
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    February 21, 2014
    Report Date
    May 13, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD WAS PERFORMED. INSPECTION OF THE LEAD BODY AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE RESULTED IN THE CLINICAL OBSERVATION OF DISLODGEMENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD DISLODGED, EXHIBITED UNDERSENSING AND LOSS OF CAPTURE (LOC). ADDITIONAL INFORMATION WAS RECEIVED AND INDICATED THAT THE PATIENT HAD LIGHTHEADED SYMPTOM. THE LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267606 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R S201| 4086