BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 136715 · Received March 10, 1997

    Report

    Report Number
    2649622-1997-00195
    Event Type
    Injury
    Date Received
    March 10, 1997
    Date of Event
    July 24, 1996
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ATTORNEY ALLEGES, "PLAINTIFF WAS REQ TO UNDERGO AN OPERATION & RPLCMNT OF LD BECAUSE OF DIRECT AND PROXIMATE RESULT OF NEGLIGENCE...SUFFERING PAIN, SCARRING, LOSS OF ENJ OF LIFE, ETC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Implant IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4523 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other 4023 IMPLANTABLE PACING LEAD| 7940 IMPLANTABLE PULSE GENERATOR