BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS LEAD

    MDR report key: 3153069 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05805
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MPRI
    Product Code
    DTD
    PMA / PMN Number
    K850968
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: A PROXIMAL PORTION WAS RECEIVED MEASURING 5.5 CM. THE PROXIMAL SEGMENT OF THE LEAD WAS ANALYZED AND THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO. IT WAS NOTED THAT 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 COSMETIC DEPRESSION WHILE IN VIVO, AND THE OUTER INSULATION OF THE LEAD DEVELOPED COSMETIC ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO.

    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: ADDR03, IMPLANTABLE PULSE GENERATOR (IPG), (B)(6) 2007; 4016, IMPLANTABLE PACING LEAD, (B)(6) 1986. (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 OUTER INSULATION WAS TORN ON THE RIGHT ATRIAL (RA) LEAD. THE LEAD WAS EXPLANTED AND NOT REPLACED. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD OUTER INSULATION DAMAGE. THE LEAD WAS EXPLANTED AND REPLACED. DURING IMPLANT OF THE REPLACEMENT RV LEAD, THE LEAD WAS DAMAGED. THE LEAD GOT STUCK IN THE VEIN AND THE LEAD TIP BENT. THE LEAD WAS REMOVED 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
    256156 TRANSVENOUS LEAD ADAPTOR, LEAD, PACEMAKER DTD MPRI 4016

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R