BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8645777 · Received May 28, 2019

    Report

    Report Number
    2916596-2019-02352
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    May 2, 2019
    Report Date
    July 24, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011170
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4, H4: ADDITIONAL INFORMATION MANUFACTURER'S INVESTIGATION CONCLUSIONS: THE REPORT OF COSMETIC DAMAGE TO THE SILICONE JACKET OF THE DRIVELINE WAS CONFIRMED BASED ON THE EVALUATION OF THE PHOTO SUBMITTED BY THE ACCOUNT. THE ACCOUNT SUBMITTED A PHOTO FOR REVIEW. THE PHOTO SHOWS SUPERFICIAL DAMAGE TO THE OUTER SILICONE JACKET OF THE DRIVELINE ADJACENT TO THE CONTROLLER CONNECTOR BEND RELIEF. X-RAYS OF THE INTERNAL AND EXTERNAL PORTIONS OF THE DRIVELINE WERE SUBMITTED FOR REVIEW AND APPEARED UNREMARKABLE AND DID NOT REVEAL ANY OBVIOUS SIGNS OF SHIELD BREAKDOWN. THE SUBMITTED LOG FILE (B)(4) CONTAINED DATA FROM (B)(6) 2019 THROUGH (B)(6) 2019. THE ONLY EVENTS CAPTURED WERE POWER CABLE DISCONNECT ALARMS ASSOCIATED WITH ROUTINE POWER SOURCE EXCHANGES AND LOW VOLTAGE (BATTERY) ADVISORY ALARMS ASSOCIATED WITH THE PATIENT USING DEPLETED BATTERIES. OF NOTE, THE LOG FILE CAPTURES ABNORMALLY LOW VOLTAGE READINGS WHILE THE PATIENT WAS CONNECTED TO THE PATIENT CABLE/POWER MODULE. THE ACTUAL SPEED REMAINED ABOVE THE LOW SPEED LIMIT THROUGHOUT THE LOG FILE AND THE PUMP APPEARED TO BE FUNCTIONING AS INTENDED. THE ACCOUNT COMMUNICATED THAT THE PATIENT¿S EXTERNAL DRIVELINE HAD SOME COSMETIC DAMAGE THAT COULD BE REPAIRED WITH RESCUE TAPE. THE PATIENT ALSO REPORTEDLY HAD DIFFICULTY SWITCHING CONTROLLERS. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED. THE PUMP IS NOT AVAILABLE FOR INVESTIGATION. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6). THE HM II LVAS IFU ADDRESSES DAMAGE DUE TO WEAR AND FATIGUE OF THE DRIVELINE AND INCLUDES DRIVELINE CARE INSTRUCTIONS. THE HM II LVAS PATIENT HANDBOOK CONTAINS A SECTION ON ¿CARING FOR THE DRIVELINE¿, HOWEVER, ALL HEARTMATE II LVAD DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT UPON LENGTH OF USE AND MOVEMENT/FLEXING OVER TIME. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE- 7 YEARS, 10 MONTHS. THE PATIENT REMAINS ONGOING WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2011. IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT AND HIS WIFE SWITCHED THE CONTROLLER AT HOME DUE TO LVAD INTERMITTENT ALARMS. ALTHOUGH THE PERCUTANEOUS LEAD (DRIVELINE) WAS DISCONNECTED DUE TO AN INTENTIONAL SYSTEM CONTROLLER EXCHANGE, IT WAS REPORTED THE PATIENT HAD DIFFICULTY RECONNECTING THE DRIVELINE. INTERRUPTION IN LVAD SUPPORT OCCURRED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES AND IT WAS REPORTED THE PATIENT IS DOING WELL. NOTHING CONCERNING WAS NOTED UPON INTERROGATION OF THE LVAD BY THE CLINICIAN. IMAGES WERE SUBMITTED OF THE EXTERNAL DRIVELINE WHICH DID SHOW SOME COSMETIC DAMAGE. IT WAS ADVISED TO REPAIR THE COSMETIC DAMAGE WITH RESCUE TAPE. SUBMITTED X-RAYS DID NOT SHOW ANY OBVIOUS AREAS OF CONCERN IN THE DRIVELINE. ON (B)(6) 2019 IT WAS REPORTED THE PATIENT CAME BACK TO THE CLINIC, AND IS STILL HAVING INTERMITTENT ALARMS AT NIGHT WHILE CONNECTED TO THE POWER MODULE. ABBOTT TECHNICAL SERVICES REVIEWED SUBMITTED LOG FILES AND CONFIRMED THE LOG FILE FOR PATIENT CONTAINED ABNORMALLY LOW VOLTAGE READINGS ON THE PATIENT CABLE CAUSING THE POWER CABLE FAULT ALARMS. IT WAS DETERMINED THE ALARMS ARE NOT ASSOCIATED WITH A DRIVELINE ISSUE. THE PATIENT CABLE WAS REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441067 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 104911 00813024011170

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR