BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA VR

    MDR report key: 2811580 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06323
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S211
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POSSIBLE INFECTION HAD OCCURRED. IT WAS FURTHER REPORTED THAT AN INCISION AND DRAINAGE WAS PERFORMED FOR A POCKET HEMATOMA AND DUE TO POSSIBLE INFECTION THE DEVICE 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
    1 PROTECTA VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D334VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R COMPETITOR IMPLANTABLE TACHY LEAD