BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2123708 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-07996
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 2, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 AND NO ANOMALIES WERE FOUND. HOWEVER, THERE WAS AN OUTER ISULATION BREACHED CUT AND APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD MIGRATED AFTER BEING IMPLANTED FOR UNKNOWN REASONS. PATIENT IS PACEMAKER DEPENDENT AND THE PHYSICIAN FELT THAT AN ACTIVE FIXATION LEAD WOULD BE MORE APPROPRIATE. NO PATIENT COMPLICATIONS WERE 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. 5054 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| P1501DR IMPLANTABLE PULSE GENERATOR