BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSY, CABLE, PM, PATIENT, 14V

    MDR report key: 8735884 · Received June 26, 2019

    Report

    Report Number
    2916596-2019-02891
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    June 11, 2019
    Report Date
    September 30, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011217
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF COSMETIC DAMAGE TO THE DRIVELINE COULD NOT BE CONFIRMED AS THERE WAS NO PRODUCT RETURNED FOR ANALYSIS AND NO PHOTOS WERE SUBMITTED FOR EVALUATION. ADDITIONALLY, THE SUBMITTED LOG FILES CONTAINED NO UNUSUAL EVENTS INDICATING AN ISSUE WITH THE DRIVELINE. NO ATYPICAL ALARMS WERE CAPTURED AND THE PUMP OPERATED ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE LOG FILE. THE LOG FILE APPEARED TO SHOW THE SYSTEM OPERATING AS INTENDED. THE PATIENT REMAINS ONGOING ON VAD SUPPORT. THE HM II LVAS IFU CONTAINS INFORMATION ON CARING FOR THE DRIVELINE AND ADDRESSES DAMAGE DUE TO WEAR AND FATIGUE OF THE DRIVELINE. THE HMII LVAS IFU EXPLAINS THAT PUMP FLOW IS ESTIMATED FROM THE PUMP POWER AND NOTES THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 6 YEARS 5 MONTHS (THE AGE IS CALCULATED FROM THE DATE OF IMPLANT TO THE EVENT DATE). THE PATIENT REMAINS ON LVAD SUPPORT WITH NO FURTHER ISSUES REPORTED. 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) 2013. IT WAS REPORTED THE PATIENT WAS SEEN FOR A FOLLOW VISIT AND NOTED TO HAVE TWISTING OF DRIVELINE (DL) WITH MULTIPLE PORTIONS COVERED WITH RESCUE TAPE. INTERROGATED DUE TO CONCERN OF INTEGRITY OF WIRES INSIDE DRIVELINE. ON INTERROGATION OF DEVICE, PATIENT HAD NO EXTERNAL POWER ALARM ON (B)(6) THAT OCCURRED WHEN SWITCHING WHITE LEAD ON PATIENT CABLE. THE LOG FILE WAS REVIEWED. THE LOG FILE ANALYSIS SHOWED THE NO EXTERNAL POWER ON (B)(6) 2019 WHILE THE PATIENT WAS SWITCHING POWER SOURCES. THE DL DATA APPEARED NORMAL SO THE TWISTING HAD NOT DEGRADED THE CONDUCTORS AT THIS TIME. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE. THE MCS EQUIPMENT WAS OPERATING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527914 ASSY, CABLE, PM, PATIENT, 14V LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 105903 1101609280 00813024011217

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention