BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3051847 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04927
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4) THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE INNER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO MIO (METAL ION OXIDATION) WHILE IN VIVO. THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO, THE OUTER INSULATION OF THE LEAD DEVELOPED COSMETIC MIO (METAL ION OXIDATION) AND COSMETIC ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO. THE INNER INSULATION OF THE LEAD DEVELOPED COSMETIC (MIO) METAL ION OXIDATION WHILE IN VIVO. VISUAL ANALYSIS FOUND BOTH INSULATIONS BREACHED/IN-VIVO AND THESE BREACHED INSULATIONS DID CONTRIBUTE TO THE REPORT OF OVERSENSING. THERE WAS NO CONDUCTOR FRACTURE OBSERVED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4): 4024-58 IMPLANTABLE PACING LEAD 2002-(B)(6). KDR901 IMPLANTABLE PULSE GENERATOR (IPG) 2002-(B)(6). (B)(4).

    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'S RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD BOTH HAD POLARITY SWITCHES AND OVERSENSING AND NOICE WERE SEEN ON AN ELECTROGRAM. LEAD FRACTURES ON BOTH LEADS WERE SUSPECTED. THE RA AND RV LEADS WERE 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
    153476 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4524

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R