BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZINGER MEDIUM

    MDR report key: 3745252 · Received April 11, 2014

    Report

    Report Number
    1220452-2014-00019
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQT
    PMA / PMN Number
    K983927
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE GUIDEWIRE WAS RETURNED, ANALYZED AND THE STYLET/GUIDEWIRE WAS BROKEN AND DAMAGED. THE GUIDEWIRE WAS UNRAVELED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE REPOSITIONING THE LEFT VENTRICULAR (LV) LEAD UNDER X-RAY DUE TO A DISLODGEMENT, UPON PULLING THE GUIDEWIRE OUT OF THE LV LEAD, THE GUIDEWIRE BROKE. THE LV LEAD WAS EXPLANTED WITH MOST OF THE GUIDEWIRE INCLUDED, HOWEVER, ONE SEGMENT OF THE WIRE REMAINED INSIDE THE PATIENT'S ATRIUM. THE LV LEAD WAS REPLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222710 ZINGER MEDIUM OCCLUDER, CATHETER TIP DQT MEDTRONIC, INC LVZRMS180S GR577

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention 419488 IMPLANTABLE PACING LEAD