BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4832554 · Received June 10, 2015

    Report

    Report Number
    2916596-2015-01072
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    May 9, 2015
    Report Date
    May 13, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION. - DEVICE EVALUATION: THE REPORT OF LOW SPEEDS, LOW FLOWS, AND A PUMP STOPPAGE WAS CONFIRMED BASED ON THE INFORMATION CONTAINED IN THE SUBMITTED LOG FILE; HOWEVER, DAMAGE TO THE PERCUTANEOUS LEAD (LEAD) WAS NOT CONFIRMED. A SECTION OF LEAD APPROXIMATELY 10 INCHES FROM THE CONNECTOR WAS RETURNED FOR EVALUATION FOLLOWING THE DISTAL END LEAD REPLACEMENT. THE SILICONE SLEEVE WAS RETURNED CUT. ELECTRICAL CONTINUITY TESTING DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS PRIOR TO REMOVING THE PLASTIC SHIELD. NO DAMAGE TO THE BIONATE LAYER WAS OBSERVED. BREAKDOWN OF THE METAL SHIELDING WAS IDENTIFIED APPROXIMATELY 2.5 INCHES FROM THE METAL CONNECTOR. VISUAL INSPECTION OF THE WIRE FOUND NO FRACTURE OR BREACH. THE LEAD WAS SUBMERGED IN A SALINE BATH FOR HIGH POTENTIAL TESTING TO CHECK THE RESISTANCE OF EACH WIRE'S INSULATION. THE TEST DID NOT REVEAL ANY CURRENT LEAKAGE IN THE INSULATION OF ANY OF THE WIRES THAT WOULD HAVE RESULTED IN AN ELECTRICAL SHORT. THE EVALUATION COULD NOT CONFIRM THE LOCATION OF THE SUSPECTED WIRE ISSUE. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 2 YEARS AND 7 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT LOW SPEED AND LOW FLOW ALARMS AND A PUMP STOPPAGE AT 10:53 PM ON (B)(6) 2015 WERE OBSERVED ON THE PATIENT HISTORY SCREEN; HOWEVER, THE PATIENT WAS UNABLE TO RECALL THE DETAILS OF THE ALARM CONDITIONS. IT WAS ALSO REPORTED THAT THE PATIENT NOTICED THAT ALARMS WOULD OCCUR IN THE PAST WHEN THERE WAS A KINK OR TWIST IN THE PERCUTANEOUS LEAD PAST THE ANCHORED AREA; HOWEVER, THE PATIENT COULD NOT RECALL THE LAST TIME THIS HAPPENED. THE PATIENT¿S LOG FILE AND X-RAY IMAGES OF THE PERCUTANEOUS LEAD (LEAD) WERE OBTAINED AND APPEARED TO INDICATE A POSSIBLE LEAD ISSUE AND AN AREA OF CONCERN NEAR THE TAPERED EDGE OF THE DISTAL END BEND RELIEF. THE LEAD WAS EVALUATED AND A DISTAL END PERCUTANEOUS LEAD REPLACEMENT WAS PERFORMED ON (B)(6) 2015; HOWEVER, LOW SPEED AND PUMP OFF EVENTS OCCURRED IMMEDIATELY AFTER THE SYSTEM WAS RECONNECTED TO THE POWER MODULE VIA A GROUNDED PATIENT CABLE. THE PATIENT WAS ASSIGNED A MODIFIED, UNGROUNDED PATIENT CABLE AND REMAINS ONGOING ON SUPPORT. IT WAS REPORTED THAT THE PATIENT HAS SOME RIGHT HEART COMPROMISE AND RENAL ISSUES, SO THERE WERE NO IMMEDIATE PLANS FOR A PUMP EXCHANGE, BUT IT IS BEING CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380577 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR