BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3991588 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02128
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS CONCERNED THAT FOR THIS MODEL LEAD THE ANCHOR SLEEVE IS NOT HOLDING THE LEAD IN PLACE ONCE TIGHTENED. THERE HAVE BEEN A NUMBER OF CASES WHERE THE LEAD SLIPS IN THE SLEEVE AND DISLODGES. REVISION IS NECESSARY. THE PHYSICIAN FELT THAT THE DESIGN OF THIS MODEL LEAD MAY CAUSE HIGHER THAN NORMAL DISLODGEMENT RATES, AS THE LEAD HAS A SMALLER DIAMETER AND IS MADE WITH A MATERIAL THAT MAY HAVE A LOWER COEFFICIENT OF FRICTION WITH THE SUTURE SLEEVE. THERE IS ALSO CONCERN THAT APPLYING EXTRA TENSION TO SUTURES HAS THE POTENTIAL TO DEFORM THE LEAD BODY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471701 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4074

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R