BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1864727 · Received October 12, 2010

    Report

    Report Number
    2649622-2010-10952
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    July 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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) NO ANOMALIES FOUND. PROXIMAL CONDUCTOR DISTORTED. BLOOD WAS NOTED ON THE HELIX/LOBE MECHANISM. FULL LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA ONE DAY POST PACEMAKER IMPLANT. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD HAD HIGH THRESHOLDS AND OVERSENSING. THE PACEMAKER AND LEADS WERE REPLACED WITH AN ICD AND ASSOCIATED LEADS. NO FURTHER PATIENT COMPLICATIONS WERE 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 74 YR Required Intervention