BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 3152129 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01175
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. P1501DR IMPLANTABLE PULSE GENERATOR, (B)(6) 2005; 4968 IMPLANTABLE PACING LEAD, (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGE OUT, WHEN THE PHYSICIAN WAS ATTEMPTING TO OPEN THE CAPSULE SURROUNDING THE IMPLANTED DEVICE/LEADS, THE RIGHT VENTRICULAR (RV) LEAD WAS SEVERED. THE DEVICE WAS INTERROGATED WHILE STILL IN THE POCKET AND THE IMPEDANCE ON THE RV WAS GREATER THAN 3000 OHMS, WHICH CONFIRMED IT WAS THE AFFECTED LEAD. THE LEAD WAS 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
    253338 CAPSURE EPI ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R