BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 2791709 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15155
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS CAPPED/NOT USABLE. FOLLOW-UP WITH THE CLINIC REVEALED THAT THE LEAD WAS NON-FUNCTIONAL AND HAD BEEN CAPPED SEVERAL YEARS AGO. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4503

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R 7071A IMPLANTABLE PULSE GENERATOR| 4003 IMPLANTABLE PACING LEAD