BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2913162 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16855
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. VISUAL INSPECTION REVEALED DEFORMED CONDUCTOR COILS ALONG WITH MARKS IN THE INSULATION FROM A GRABBING TOOL 295-298MM FROM THE TERMINAL PIN. THE HELIX WAS PARTIALLY EXTENDED AND THE LEAD TIP APPEARED INTACT AND UNDAMAGED. THERE WAS DRIED BLOOD/BODY FLUID IN THE HELIX HOUSING AND PAST THE WINDOW AREA WITH MOST LIKELY DID NOT ALLOW THE HELIX TO FULLY EXTEND.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT TWO DAYS FOLLOWING THE IMPLANT PROCEDURE, THE PATIENT PRESENTED WITH SYMPTOMS OF HIGH THRESHOLD MEASUREMENTS AND LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. A CHEST RADIOGRAPH WAS PERFORMED WHICH INDICATED THE HELIX WAS NOT EXTENDED. AS A RESULT, A REVISION PROCEDURE WAS PERFORMED. THE HELIX WAS EXTENDED ON THE RV LEAD AND ALL MEASUREMENTS WERE APPROPRIATE. THEREFORE, THE DECISION WAS MADE TO LEAVE THE LEAD IMPLANTED. AS THE TEMPORARY PACING WIRE WAS TURNED OFF, THE PATIENT EXPERIENCED EXTREME BRADYCARDIA. WHEN THE LEADS WERE REVIEWED UNDER FLUOROSCOPY, THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED AND THE RV LEAD HAD ABNORMAL MOVEMENT OF THE TIP. AS A RESULT, THE DECISION WAS MADE TO REPLACE BOTH LEADS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21184 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R