BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2811074 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16087
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. EVALUATION SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION. ONLY VISUAL ANALYSIS WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LOW IMPEDANCE AND A POTENTIAL INSULATION ISSUE WITH THE LEAD. THE LEAD WAS PARTIALLY 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
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4024

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR