BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1922551 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13002
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. HOWEVER, THERE WAS A COSMETIC OUTER INSULATION DEPRESSION. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND IT WAS FOUND THAT THE OUTER INSULATION WAS BREACHED LIKELY DUE TO CLAVICLE RIB CRUSH. IT WAS ALSO NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR, BUT THAT THIS WAS NOT OBSTRUCTING. THE OUTER INSULATION ALSO HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT INDICATED THAT THEY COULD FEEL THE PACING. AN X-RAY WAS TAKEN WHICH SHOWED THAT THE LEADS HAD MARKEDLY PULLED BACK IN BOTH CHAMBERS. BOTH LEADS WERE REMOVED 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 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5554 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR