BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000094-2013-00011

    MDR report key: 2965654 · Received February 15, 2013

    Report

    Report Number
    6000094-2013-00011
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 20, 2012
    Manufacturer
    MEDTRONIC S.A. (SMO)
    Product Code
    LWS
    PMA / PMN Number
    P010031
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A VENTRICULAR TACHYCARDIA (VT) EPISODE AND THE SHOCK THERAPY WAS INEFFECTIVE. THEREFORE RV LEAD WAS REPOSITIONED AND TESTED WITH RESULTING INEFFECTIVE SHOCK THERAPY. THEREFORE, THE RV LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67910 LWS MEDTRONIC S.A. (SMO) DTBA2D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| R 6935M IMPLANTABLE TACHY LEAD