BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3991500 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08085
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    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 MEDICAL PRODUCTS: SEDR01, IPG, IMPLANTED: (B)(6) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO.

    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 THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW PACING IMPEDANCE. IN ADDITION, THERE WAS INSULATION DAMAGED NOTED ON THE PROXIMAL END OF THE RIGHT ATRIAL (RA) LEAD. THE RV AND RA LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469355 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4524-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 402458 LEAD