BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1874761 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11539
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 6, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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; FULL LEAD WAS RETURNED AND ANALYZED. PROXIMAL CONDUCTOR DISTORTED AND PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL POST IMPLANT AND SUSTAINED A CERVICAL FRACTURE. THE PHYSICIAN BELIEVES IT CAUSED THE ATRIAL LEAD TO DISLODGE. THE LEAD WAS REMOVED AND RETURNED. A NEW ACTIVE FIXATION LEAD WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5554 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 5092 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER