BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3213627 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09307
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO PRODUCT PERFORMANCE ISSUE. ADDITIONAL INFORMATION WAS OBTAINED FROM FIELD REPRESENTATIVE REVEALED THE RV LEAD HAD DISLODGED TWICE. THE RV LEAD WAS NOT RETURNED BECAUSE THE HOSPITAL KEPT IT. THE RV LEAD IS NO LONGER IN SERVICE AND REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314118 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R V173| 4592| 4088| 0181| 4548| K062