BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 2811347 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05815
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    July 26, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    Z-0115-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE DEVICE WAS RETURNED AND ANALYZED. THE ACTUAL LONGEVITY WAS LESS THAN 80% OF THE 99.9% LONGEVITY LIMIT. THE DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. FURTHER ANALYSIS REVEALED THERE WAS NO PROBLEM WITH THE BATTERY. ADDITIONALLY, THE HYBRID WAS SUBMITTED FOR MEMORY TESTING AND ALL TESTS PASSED. THIS DEVICE WAS INCLUDED IN A FIELD ACTION AND RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY : (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL, INC. D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R 6932 IMPLANTABLE TACHY LEAD| 305C25 TISSUE VALVE| 310C27 TISSUE VALVE| 6940 IMPLANTABLE PACING LEAD