BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUIS

    MDR report key: 3160508 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10117
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-0597-05
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY #PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE RETURNED DEVICE WAS NOT PERFORMED BUT THE DEVICE MET THE EXPECTED LONGEVITY. PERFORMANCE DATA COLLECTED FROM THE DEVICE MEMORY INDICATED THE LOW BATTERY VOLTAGE ALERT FOR RRT (RECOMMENDED REPLACEMENT TIME), ANALYSIS OF THE DEVICE MEMORY INDICATED POWER-ON RESET PARAMETERS WERE PRESENT. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # ANALYSIS OF THE RETURNED DEVICE WAS NOT PERFORMED BUT THE DEVICE MET THE EXPECTED LONGEVITY. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED A POWER ON RESET (POR). THE DEVICE WAS EXPLANTED AFTER REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261019 MARQUIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO 7230CX

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD