BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2813447 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17250
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATRIAL LEAD HAD LOC (LOSS OF CAPTURE), HOWEVER AFTER LEAD TESTING THROUGH THE ANALYZER THRESHOLDS WERE NORMAL. PHYSICIAN THEN BELIEVED THE ISSUE WAS WITH THE DEVICE REGARDING THE ATRIAL CIRCUIT. THE DEVICE WAS EXPLANTED AND REPLACED. THE ATRIAL LEAD WAS THEN TESTED WITH THE NEW DEVICE AND TESTED WNL (WITHING NORMAL LIMITS). THE ATRIAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN 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. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD