BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC/MEDTRONIC

    MDR report key: 166215 · Received February 2, 1998

    Report

    Report Number
    166215
    Event Type
    Injury
    Date Received
    February 2, 1998
    Date of Event
    January 19, 1998
    Report Date
    February 2, 1998
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OPERATIVE PROCEDURE ON 1/19/1998 PRE/POST DIAGNOSIS - "PCD" FAILURE. "PT UNDERWENT A RIGHT-SIDED PCD PLACEMENT A COUPLE OF DAYS AGO. HE NOW PRESENTS WITH PCD FAILURE. MEDTRONIC CO, UPON INTERROGATION OF THE DEVICE, FELT THAT THE LEAD WAS DEFECTIVE OR THE PCD GENERATOR WAS DEFECTIVE. THEREFORE DECISION WAS MADE TO REPLACE THE ENTIRE SYSTEM AND PUT IN A NEW SYSTEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC/MEDTRONIC Implant GENERATOR/LEADS DXY MEDTRONIC INC. 7271/6933 & 6943 TCE003065R

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention