BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 12V SLA BATTERY CLIP

    MDR report key: 2052122 · Received March 1, 2011

    Report

    Report Number
    2916596-2011-00084
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    2916596101409-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED. THE REPORT OF A LOOSE BATTERY CLIP CONNECTOR IS CURRENTLY BEING ADDRESSED THROUGH THE MFR'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE RECALL (291659-10/15/09-001-R) HAS BEEN ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADED CONNECTOR OF THE BATTERY CLIP THAT SCREWS INTO THE SYSTEM CONTROLLER ROTATED WITHIN THE HOUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE 12V SLA BATTERY CLIP LVAD BATTERY CLIP DSQ THORATEC CORP. 1237 34477720108

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other