BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 2131898 · Received June 16, 2011

    Report

    Report Number
    2647346-2011-00877
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE INITIAL REPORT OF INFECTION WAS RECEIVED ON (B)(6) 2011 AND IS NORMALLY SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORTING (ASR). INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2011 THAT REVEALED A SERIOUS INJURY FOR THE DEVICE, (B)(4). AS THERE IS NEW INFORMATION FOR THE DEVICE, THIS DEVICE NO LONGER QUALIFIES FOR ASR, AND IS THEREFORE BEING ADDED TO THE SUPPLEMENTAL MEDWATCH REPORT. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS FRACTURED. THE LEAD INTEGRITY ALERT ALARM HAD TRIGGERED. AT THE TIME OF THE REPLACEMENT SURGERY, INFECTION WAS DISCOVERED. THE LEAD WAS REMOVED AND LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IN ADDITION, THE PATIENT LATER REPORTED THE INFECTION CONTINUED RESULTING IN READMISSION TO THE HOSPITAL, AND NOTED BEING SEPTIC AND HAVING A BLOOD CLOT. THE DEVICE WAS ALSO REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRUST VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R