BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3160361 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-08016
    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
    P830061
    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; 5092, 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 39.5 CM. NO ANOMALIES WERE FOUND. THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. THE OUTER INSULATION ON THE LEAD WAS EXTRINSICALLY BREACHED DUE TO MELTING AND IT DEVELOPED COSMETIC METAL ION OXIDATION WHILE IN VIVO. THE OUTER INSULATION OF THE LEAD ALSO DEVELOPED COSMETIC ENVIRONMENTAL STRESS CRACKING WHILE IN VIVO. 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
    261191 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4524-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R