BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3160403 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-08001
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. CONCOMITANT PRODUCTS: ADDR01 IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2011; 4524 IMPLANTABLE PACING LEAD (B)(6) 2001. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DISTAL PORTION OF THE LEAD WAS RETURNED AND ANALYZED. THE SEGMENT MEASURED 42.5 CM. NO ANOMALIES WERE FOUND. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY CUT BUT NOT BREACHED. A COSMETIC WHITE SUBSTANCE THAT DEVELOPED IN VIVO ON THE OUTER INSULATION OF THE LEAD WAS OBSERVED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE AND LEADS WERE REMOVED DUE TO INFECTION WITH VEGETATION ON THE LEADS. A NEW DEVICE AND LEADS WERE IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260271 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5092-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R