BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE IMPLANTABLE PNEUMATIC LEFT VENTRICULAR ASSIST SYST

    MDR report key: 173368 · Received June 19, 1998

    Report

    Report Number
    1218444-1998-00013
    Event Type
    Injury
    Date Received
    June 19, 1998
    Date of Event
    May 23, 1998
    Report Date
    May 23, 1998
    Manufacturer
    THERMO CARDIOSYSTEMS, INC.
    Product Code
    DSQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H11. IN THE INITIAL MEDWATCH REPORT FILED ON 06/19/1998, THERE WAS A LINE IN SECTION H10 THAT READ AS FOLLOWS: "THE PERC TUBE CONNECTION TO THE LOWER HOUSING OF THE LVAD AT THE NIPPLE HAS BEEN REDISIGNED, VALIDATED, SUBMITTED AND APPROVED BY FDA ON MAY 1, 1997 IN P920014/506. THIS LINE SHOULD HAVE READ AS FOLLOWS: (CORRECTED VERSION) "...REDESIGNED, VALIDATED AND SUBMITTED TO FDA ON MAY 1, 1997 IN P920014/506. P920014/506 WAS APPROVED BY FDA ON MAY 22, 1997." NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    ON 5/23/1998, THE MFR REC'D A CALL CONCERNING A SUSPECTED AIR LEAK FROM THE LEFT VENTRICULAR ASSIST DEVICE. THE LEFT VENTRICULAR ASSIST DEVICE HAS LOSS OF EJECTION WHICH WAS CORRECTED UPON VENTING. VENTING OF THE LEFT VENTRICULAR ASSIST DEVICE WAS REQUIRED EVERY 2 TO 5 MINUTES. THE LEFT VENTRICULAR ASSIST DEVICE DRIVE CONSOLE AND INTERCONNECT CABLE WERE CHANGED WITHOUT EFFECT. POSSIBLE SOURCES OF THE AIR LEAK AND ACTIONS TO REPAIR IT WERE DISCUSSED. THE PT WAS BROUGHT TO THE OPERATING ROOM AND THE AIR LEAK WAS CONFIRMED WHERE THE PERC TUBE CONNECTS TO THE LEFT VENTRICULAR ASSIST DEVICE. THE SURGEON REPAIRED THE LEAK BY COMPLETELY CUTTING OFF THE LEAKING PERC TUBE AND REATTACHING ANOTHER PERC TUBE FROM A BACK UP LEFT VENTRICULAR ASSIST DEVICE. THE PERC TUBE ELECTRICAL LEADS WERE CUT AND NOT REATTACHED. ON 6/16/98, IT WAS REPORTED THAT THE PT IS USING A PORTABLE PNEUMATIC DRIVE WITH THE LEFT VENTRICULAR ASSIST DEVICE TO TAKE WALKS OUTSIDE THE HOSPITAL WITH A COMPANION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE IMPLANTABLE PNEUMATIC LEFT VENTRICULAR ASSIST SYST Implant LEFT VENTRICULAR ASSIST DEVICE DSQ THERMO CARDIOSYSTEMS, INC. 1000A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R