BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX XL LV LEAD

    MDR report key: 4231362 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18142
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    August 21, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OUT OF SERVICE DATE SHOULD BE (B)(6) 2015 NOT (B)(6)2015

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING A VIBRATORY PATIENT NOTIFIER ALERT FOR AN IMPEDANCE ISSUE ON THE LEFT VENTRICULAR LEAD. THE LEAD IMPEDANCE HAD MADE A SUDDEN DROP WHICH PROMPTED THE ALERT. A FLUOROSCOPY REVEALED THAT THE LEAD INSULATION WAS ABRADED. THE LEAD REMAINED IMPLANTED AND THE PATIENT WOULD BE MONITORED.

    Description of Event or Problem · 1

    NEW INFORMATION REPORTED THAT THE CORRECT CAP DATE WAS (B)(6) 2015. A CHEST X-RAY REVEALED THAT THE LEAD HAD EXTERNALIZED CONDUCTORS.

    Description of Event or Problem · 1

    NEW INFORMATION REPORTED THAT THE PATIENT WAS IN STABLE CONDITION PRIOR, DURING AND AFTER THE SURGICAL PROCEDURE PERFORMED ON (B)(6) 2015.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED STATED THAT THE LEAD WAS CAPPED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714545 QUICKFLEX XL LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1158T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR