BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3955850 · Received June 25, 2014

    Report

    Report Number
    2916596-2014-01025
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION, HOWEVER, THE PERCUTANEOUS LEAD WAS RETURNED AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE MANUFACTURER THAT A CUSTOM MODIFIED CABLE WAS REQUESTED AND SHIPPED. THE VAD COORDINATOR REPORTED THAT THE PT HAD BEEN EXPERIENCING RED HEART ALARMS WHEN CONNECTED TO THE POWER MODULE PATIENT CABLE. THE MANUFACTURER WAS REQUESTED TO PERFORM AN ON-SITE EVALUATION. THE ANALYSIS DID NOT REVEAL ANY OPEN WIRES IN THE PERCUTANEOUS LEAD (LEAD) AND THE RED HEART ALARMS WERE NOT ABLE TO BE REPRODUCED BY MANIPULATION OF THE EXTERNAL PORTION OF THE LEAD. ONSITE REVIEW OF X-RAYS DID NOT INDICATE ANY OBVIOUS DAMAGE. THE VAD CENTER SUSPECTED POSSIBLE INTERNAL DAMAGE AND REQUESTED AN UNGROUNDED PATIENT CABLE FOR CONTINUED SUPPORT. THE PT WAS REGISTERED ON 1A TRANSPLANT STATUS AND UNDERWENT A TRANSPLANT ON (B)(6) 2014. THE PERFUSIONIST STATED THAT THEY DID NOT SAVE THE PUMP, BUT WILL BE SENDING BACK THE PERCUTANEOUS LEAD FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369854 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 105453

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male