BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 4240888 · Received November 10, 2014

    Report

    Report Number
    3007566237-2014-03278
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    December 13, 2012
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3587A, LOT# UNKNOWN, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HOSPITALIZED (B)(6) 2013, THEY WERE RE-IMPLANTED ON (B)(6) 2013 AND DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. IT WAS UNKNOWN IF ANY TESTING OR TROUBLESHOOTING HAD BEEN DONE. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS. IT WAS NOTED THERE WAS A PRODUCT ISSUE AND THAT THE ISSUE HAD RESOLVED. NO FURTHER INFORMATION WAS AVAILABLE ON THE EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED FOR ADDITIONAL INFORMATION ON REASON FOR HOSPITALIZATION AND REPLACEMENT AND PATIENT OUTCOME. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT WAS HOSPITALIZED FOR A SCAR INFECTION. THE DEVICE WAS EXPLANTED IN (B)(6) 2013 AND WAS REPLACED IN (B)(6) 2013. THE PATIENT OUTCOME WAS CONSIDERED GOOD AND THE PATIENT HAD EFFICIENT STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722839 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization| R