BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA VR

    MDR report key: 3160382 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10086
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH AN INFECTION OF UNKNOWN SOURCE APPROXIMATELY ONE WEEK POST IMPLANT AND TWO DAYS POST THE EVACUATION OF A HEMATOMA. IT WAS FURTHER REPORTED THAT THE PHYSICIAN QUESTIONED THE STERILITY OF THE DEVICE AND LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261298 SECURA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D204VRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R 6935M IMPLANTABLE TACHY LEAD