BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 61056 · Received December 27, 1996

    Report

    Report Number
    61056
    Event Type
    Injury
    Date Received
    December 27, 1996
    Date of Event
    November 18, 1996
    Report Date
    November 18, 1996
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT REPLACEMENT OF A GENERATOR PACK FOR VVIR PACEMAKER IN MORNING. THE PACEMAKER HAD BEEN IN SEVEN YEARS AND ELECTIVE REPLACEMENT HAD TAKEN PLACE WITH GOOD LEAD PARAMETERS FOUND ALTHOUGH THE PT WAS COMPLETELY PACEMAKER DEPENDENT. IN RECOVERY, IT WAS NOTED THAT THE PT WAS HAVING DIZZY SPELLS WHEN HE STOOD UP. A PACEMAKER CHECK WAS APPLIED AND THERE WERE NO INTERMITTENT EPISODES OF LACK OF STIMULATION. PRESSING ON THE POCKET SITE STARTED THE DEVICE TO PACE AGAIN. PT WAS RETURNED TO OR. THE ADAPTER WAS DISCONNECTED AND REMOVED, LEAD TESTED AND GENERATOR CONNECTED. PT WAS TRANSFERRED TO SCU FOR 24 HRS AND DISCHARGED ON 11/19/96. UPON EXPLANT, SURGEON THOUGHT THE POSITIVE SET-SCREW MIGHT NOT HAVE BEEN ENTIRELY TIGHTENED BUT THE ADAPTER WAS ALSO SUSPECT. THERE HAVE BEEN NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC Implant 5866-34 ADAPTER DTD MEDTRONIC, INC. 5866 - MEDTRONIC *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R 1) 8400 IJ2307239H PACEMAKER