BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 3160349 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-08019
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Removal / Correction Number
    N-029/030-4
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IMPLANTABLE PACING LEAD 1990 (B)(6); (B)(4) IMPLANTABLE PULSE GENERATOR 2013 (B)(6); 407658 IMPLANTABLE PACING LEAD 2005 (B)(6); 4024-52 IMPLANTABLE PACING LEAD 1994 (B)(6); 5034-52 IMPLANTABLE PACING LEAD 1996 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. A PROXIMAL PORTION WAS RECEIVED MEASURING 48 CM. A MEDIAL PORTION WAS RECEIVED MEASURING 48 CM. ANALYSIS REVEALED THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO. THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. THE OUTER INSULATION OF THE LEAD DEVELOPED COSMETIC ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.

    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 PATIENT DEVELOPED BACTEREMIA. CULTURES WERE TAKEN FROM THE DEVICE POCKET AND BLOOD. THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS WERE EXPLANTED. LASER LEAD EXTRACTION ATTEMPTED, TWO LEADS ENTIRELY REMOVED AND THREE LEADS PARTIALLY REMOVED. THE PATIENT HAD OPEN CHEST SURGERY TO REMOVE REMAINING PORTIONS OF LEADS, A TEMPORARY PACING SYSTEM WAS IMPLANTED, AND A FEW DAYS LATER REPLACED WITH A NEW PACING SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261002 CAPSURE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4004M58

    Patients

    Seq Age Sex Outcome Treatment
    1 00093 YR Hospitalization| R