BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA VR

    MDR report key: 2812886 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06562
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE TO REPLACE THE DEVICE DUE TO MEDICAL JUDGMENT. IT WAS FOUND THAT THE NEWLY IMPLANTED DEVICE WAS IMPLANTED AFTER THE USE BEFORE DATE. THIS WAS NOTICED AS THE PHYSICIAN WAS CLOSING THE POCKET. THE PHYSICIAN REOPENED THE POCKET AND THE DEVICE WAS EXPLANTED AND REPLACE. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL, INC. D334VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD