BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1922683 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13034
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 17, 2010
    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 AND ANALYZED. NO ANOMALIES WERE FOUND; HOWEVER, THE OUTER INSULATION HAD A BREACHED CUT AND A COSMETIC CUT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVEHEAD, AND APPARENT EXPLANT DAMAGE WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD DISLODGED TWICE IN THE TWO DAYS POST IMPLANT. THE LEAD WAS REPOSITIONED ONE DAY POST IMPLANT WHEN IT WAS FOUND IN THE RIGHT VENTRICLE. THE NEXT DAY, THE LEAD WAS AGAIN FOUND IN THE RIGHT VENTRICLE AND SENSING DIFFICULTIES WERE NOTED. THE PHYSICIAN BELIEVES THIS WAS DUE TO PATIENT'S ATRIAL TISSUE AND NOT A LEAD MALFUNCTION. THE LEAD WAS EXPLANTED AND REPLACED. 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 91 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PULSE GENERATOR