BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK

    MDR report key: 3990440 · Received August 7, 2014

    Report

    Report Number
    2182208-2014-02247
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EXPLANTED: (B)(6) 2014, PRODUCT ID: A 439888 LEAD IMPLANTED: (B)(6) 2014. PRODUCT ID: ST-JUDE-LEAD IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014. PRODUCT ID: ST-JUDE-LEAD, IMPLANTED: (B)(6) 2014. PRODUCT ID: A 6056M LEAD ACCESSORY. PRODUCT ID: A 229047 PACING SYSTEM ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN HAD DIFFICULTY CONNECTING THE LEFT VENTRICULAR (LV) LEAD AND THE DEVICE. THE CONNECTION WAS CONFIRMED AND THE IMPEDANCE MEASURED WITH THE PROGRAMMER. A FEW HOURS LATER TESTING WITH THE PROGRAMMER REVEALED HIGH IMPEDANCE WITH THE LV LEAD. THE PHYSICIAN DISCONNECTED AND RECONNECTED THE LV LEAD INTO THE DEVICE. THE LV IMPEDANCE WAS WITHIN NORMAL RANGE. THE READINGS USING THE PACING SYSTEM ANALYZER (PSA) SHOWED IMPEDANCE WITHIN THE NORMAL RANGE; HOWEVER, THE READINGS BETWEEN THE DEVICE AND THE PROGRAMMER DIFFERED. THE LV LEAD AGAIN WAS DISCONNECTED AND RECONNECTED DUE TO HIGH IMPEDANCE. THE PHYSICIAN DECIDED TO USE A DIFFERENT DEVICE DUE TO CONCERNS WITH THE CONNECTION AND BATTERY ON THE DEVICE. THE LV LEAD REMAINS IMPLANTED ALONG WITH THE NEW DEVICE. THE PSA AND THE PROGRAMMER WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463319 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R DTBB2QQ