BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1072657 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03999
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    April 29, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: NO ANOMALIES FOUND; FULL LEAD ANALYZED IT WAS REPORTED THE VENTRICULAR LEAD WAS EXPLANTED AND REPLACED DUE TO LEAD FRACTURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION DEVICE PERFORMED ACCORDING TO SPECIFICATIONS DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED LEAD(S), FRACTURE OF.

    Description of Event or Problem · 1

    IT WAS REPORTED THE VENTRICULAR LEAD WAS EXPLANTED AND REPLACED DUE TO LEAD FRACTURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD