BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2202921 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11577
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 WITH NO ANOMALIES FOUND. VISUAL ANALYSIS REVEALED THREE OF THE FOUR DISTAL CONDUCTORS AND FOUR OF THE SIX PROXIMAL CONDUCTORS WERE CUT AT 6.5 CM AND THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON ALL CONDUCTORS. THERE WAS A BREACHED CUT AND COSMETIC DEPRESSION ON THE OUTER INSULATION. THERE WAS BLOOD IN/ON THE HELIX MECHANISM, THE LEAD WAS STRETCHED, AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED WITH NO ANOMALIES FOUND. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON ALL CONDUCTORS. THERE WAS COSMETIC ENVIRONMENTAL STRESS CRACKING AND A BREACHED CUT ON THE OUTER INSULATION, BLOOD IN/ON THE HELIX MECHANISM, AND APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS HAD PAIN IN THE POCKET AREA SINCE IMPLANT. THE PHYSICIAN FELT THIS WAS DUE TO THE ORIGINAL IMPLANT STICK AND THE LEADS BONDING TO THE CLAVICLE. BOTH LEADS WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR