BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1862801 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10543
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    July 28, 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
    IL, 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 ANALYZED. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, THERE WAS POSITIONING/FIXATION DIFFICULTY. THE PHYSICIAN DID NOT FEEL THIS WAS DUE TO ANY LEAD PERFORMANCE ISSUE OR MALFUNCTION, RATHER THAT THE RV APEX WAS POSSIBLY SMOOTH OR LACKING ADEQUATE TRABECULAE FOR TINE FIXATION. THE LEAD MIGRATED SPONTANEOUSLY AFTER SEVERAL ATTEMPTS AT RV APICAL PLACEMENT, AND OFTEN APPEARED TO "SLIDE" UP LIKELY THE RV FREE-WALL. THE POSITIONING DIFFICULTY RESULTED IN LOW R-WAVE AMPLITUDE AND THRESHOLDS OF AT LEAST 4.0 V. THE LEAD WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN 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 82 YR Required Intervention