BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1921414 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12510
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 2, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    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, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE HELIX WAS DISTORTED/BENT AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH THE GUIDE TOOTH DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THRESHOLD OF THE ATRIAL LEAD HAD ELEVATED SHORTLY AFTER IMPLANT. IT WAS THEN DISCOVERED THAT THE LEAD HAD DISLODGED. THE ATRIAL LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention 6947 IMPLANTABLE TACHY LEAD| D284TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5071 IMPLANTABLE PACING LEAD