BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 2201988 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11252
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 9, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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): DISTAL CONDUCTOR DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE DISTAL CONDUCTOR FRACTURED DUE TO OVERSTRESS, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD APPEARED DAMAGE AT IMPLANT; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, WHILE THE LEAD WAS BEING REPOSITIONED, THE PHYSICIAN RETRACTED THE HELIX BUT IT WOULD NOT LATER EXTEND. IT WAS ALSO NOTED THAT THE STYLET SEEMED TO NEED AN EXCESSIVE AMOUNT OF FORCE TO REMOVE IT FROM THE LEAD. THE LEAD WAS NOT USED AND 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 93 YR Other (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD