BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1990445 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-01997
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED) AND THE OUTER INSULATION WAS BREACHED CUT. IT WAS NOTED THAT THE STEROID RING WAS DAMAGED DURING ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTED LEAD BECAME DISLODGED AND A NEW LEAD WAS ATTEMPTED TO BE IMPLANTED. THE SECOND LEAD WAS NOT IMPLANTED AS NOISE WAS OBSERVED ON THE ANALYZER. 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 76 YR Hospitalization| R COMPETITOR IMPLANTABLE PACING LEAD| COMPETITOR IMPLANTABLE PULSE GENERATOR