BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 3864821 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11343
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    December 16, 2013
    Report Date
    April 10, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    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

    THIS REPORT IS BASED SOLELY ON DEVICE 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. THIS DEVICE WAS INCLUDED IN A FIELD ACTION AND RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY : THE DEVICE WAS RETURNED AND ANALYZED; ANALYSIS REVEALED TELEMETRY B (WIRED) WAS FUNCTIONAL, BUT TELEMETRY C (WIRELESS) WAS NOT. FURTHER TESTING TO DETERMINE THE FAILURE MECHANISM OF TELEMETRY C WAS PERFORMED AND IT WAS DETERMINED THAT IT WAS CAUSED BY A FAULTY INTEGRATED CIRCUIT (IC). STATIC CURRENT DRAIN FAILURES WERE OBSERVED DURING IC TESTING. CONCOMITANT PRODUCT: 4076-45, LEAD, IMPLANTED (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO AN UPGRADE. 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
    338523 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R 6947-58 LEAD