BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2203119 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11650
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 19, 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
    AR, 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 FOR (B)(4): THE FULL LEAD WAS RETURNED AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD/ BODY FLUID NOTED (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THE RIGHT ATRIAL LEAD WAS CUT RESULTING IN AN APPARENT CONDUCTOR FRACTURE. THE LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR LEAD COULD NOT BE PLACED DUE TO POSITIONING/FIXING DIFFICULTIES. THE LEAD WAS NOT IMPLANTED AND A DIFFERENT LEAD WAS USED. NO 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 75 YR Hospitalization| R VEDR01 IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD