BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3151532 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05501
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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. PRODUCT EVENT SUMMARY: THE DISTAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND, VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. (B)(4) IMPLANTABLE PULSE GENERATOR 2006-(B)(6); 5038 IMPLANTABLE PACING LEAD 1999-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) IMPLANTABLE PACING LEAD WAS EXHIBITING INCREASING IMPEDANCE AND THRESHOLDS. THE PHYSICIAN PROPHYLACTICALLY REPLACED THE RV LEAD USING LASER LEAD EXTRACTION (LLE). DURING THE REVISION PROCEDURE, THE RIGHT ATRIUM (RA) IMPLANTABLE PACING LEAD WAS DISLODGED AND WAS CONSEQUENTLY 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
    253379 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 452353S

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R