BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD SERVICE KIT

    MDR report key: 2525548 · Received April 10, 2012

    Report

    Report Number
    2182208-2012-01170
    Event Type
    Malfunction
    Date Received
    April 10, 2012
    Date of Event
    March 23, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4), THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. FOREIGN MATERIAL WAS NOTED IN THE SET SCREW. THE (B)(4) AND RATCHET WRENCHES WERE BROKEN. THE ANALYST NOTED A PIECE OF BROKEN WRENCH IN THE VENTRICULAR SETSCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE DEVICE IMPLANT ATTEMPT A WRENCH TOOL BROKE IN THE DEVICE HEADER. THE DEVICE WAS NOT USED AND WAS REPLACED. IT WAS FURTHER REPORTED THAT TWO ADDITIONAL RATCHET WRENCHES BROKE DURING THE DEVICE CHANGEOUT PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD SERVICE KIT KFJ MEDTRONIC, INC. 5873W

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other SELOXJT COMPETITOR IMPLANTABLE PACING LEAD| SELOXST COMPETITOR IMPLANTABLE PACING LEAD