BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1802688 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08735
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    June 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION: CHANGE EVENT LOCATION FROM UNK TO HOSPITAL. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. OUTER INSULATION BREACHED CUT AND BLOOD IN/ON HELIX MECHANISM. FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS REPOSITIONED SEVERAL TIMES AND HAD HIGH THRESHOLDS IN ALL LOCATIONS. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS 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 79 YR Required Intervention 4076 IMPLANTABLE PACING LEAD| VEDR01 IMPLANTABLE PULSE GENERATOR