BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2123577 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-07980
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 3, 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. NO ANOMALIES FOUND. IT WAS NOTED THAT THE OUTER INSULATION BREACHED WAS CUT, WITH BLOOD IN/ON HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED THE DAY AFTER IMPLANT WITH NO CAPTURE OR SENSING ON THE RIGHT VENTRICULAR LEAD. A NEW PROCEDURE WAS PERFORMED TO REPOSITION THE LEAD. A PERFORATION WAS FOUND. THE LEAD WAS EXPLANTED AND REPLACED. NOTABLY, REMOVAL OF THE LEAD WAS ACCOMPANIED BY A LOSS OF BACK AND ANTERIOR CHEST PAIN. NO FURTHER 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD