BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 1863078 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10427
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    July 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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) FULL LEAD WAS ANALYZED. ANALYSIS INDICATES THAT DISTAL CONDUCTOR IS DISTORTED. THE HELIX WOULD NOT EXTEND OR RETRACT DUE TO DISTAL CONDUCTOR DISTORTION WITHIN THE CONNECTOR. BLOOD/BODY FLUID (NOT OBSTRUCTED) WAS FOUND ON THE DISTAL CONDUCTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, THE "SETSCREW" (HELIX) WOULD NOT ENGAGE. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5568 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention