BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 4161751 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11421
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO, AND THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT; PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

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

    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: ADDR01 IPG, IMPLANTED: (B)(6) 2008; UNK PLASMA BLADE: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WAS FRACTURED. DURING THE REPLACEMENT PROCEDURE, AFTER USING A PLASMA BLADE ELECTROCAUTERY DEVICE TO CLEAR THE POCKET OF SCAR TISSUE, THE PHYSICIAN NOTICED "NICKS" IN THE OUTER INSULATION OF BOTH THE ATRIAL AND RV (RIGHT VENTRICULAR) LEADS. THE PHYSICIAN WAS NOT SURE IF THE INSULATION ISSUES WERE PRE-EXISTING OR WERE CAUSED BY THE USE OF ELECTROCAUTERY. THE LEADS WERE AT LEAST PARTIALLY EXPLANTED 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
    640722 CAPSURE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4003M58

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| R 4557M-53 LEAD