BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 3051171 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05940
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    October 30, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4). THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED ANALYSIS WAS PERFORMED AND NO ANOMALIES WEREFOUND. THE DEVICE WAS RETURNED AND ANALYZED BUT NO ISSUE IDENTIFIED THAT REQUIRED FULL ANALYSIS. INITIAL SET OF DATA FILES CREATEDAT AUTO-INTERROGATE FOR THIS DEVICE DID NOT CONTAIN ALL THE INFORMATION NECESSARY TO PERFORM ANALYSIS, THEREFORE THE DEVICE WAS RETESTED AND THE NEW DATAFILES WERE ENTERED INTO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: PRODUCT ID 5076-52 IMPLANTED: (B)(6) 2011; PRODUCT ID 694765 IMPLANTED: (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. BACTEREMIA WITH VEGITATIVE GROWTH ON THE RIGHT VENTRICULAR (RV) LEAD WASNOTED. IT WAS FURTHER REPORTED THAT THE PATIENT COMPLAINED OF NECK PAIN AND HEADACHE. "MENTAL STATUS CHANGES" WERE NOTED. THE SYSTEM WAS REPLACED. THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148935 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R