BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2203275 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11679
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED WITH NO ANOMALIES FOUND. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON THE PROXIMAL CONDUCTOR. THE OUTER INSULATION WAS MELTED, HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, AND A BREACHED CUT. THERE WAS BLOOD IN/ON THE HELIX MECHANISM, THE LEAD HAD APPARENT EXPLANT DAMAGE, AND THERE WAS A WHITE SUBSTANCE ON IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD HAD HIGH OUTPUTS, HIGH THRESHOLDS AND VARYING IMPEDANCE. THE LEAD WAS EXPLANTED AND 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. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| 430-10 COMPETITOR IMPLANTABLE PACING LEAD