BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 6175861 · Received December 15, 2016

    Report

    Report Number
    3004209178-2016-26486
    Event Type
    Injury
    Date Received
    December 15, 2016
    Report Date
    December 14, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994130
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3487A-33, LOT# V091227, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED BY THE REP THAT THE PATIENT HAD THEIR SYSTEM EXPLANTED DUE TO THE LEAD ERODING THROUGH THE SKIN. THERE WERE NO KNOWN FACTORS ATTRIBUTING TO THE EVENT AND NO DIAGNOSTICS OR TROUBLESHOOTING PERFORMED. THE PATIENT HAD THEIR SYSTEM EXPLANTED A WEEK PRIOR TO THE REPORT AND THE ISSUE WAS CONSIDERED TO BE RESOLVED AT THE TIME OF THE REPORT. THE PRODUCTS WERE DISCARDED BY THE CUSTOMER AND NOT AVAILABLE FOR ANALYSIS. ALL INFORMATION WAS PROVIDED AND REQUIRED FIELDS DEEMED SUFFICIENT SO NO FOLLOW-UP WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825449 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7425 00613994130

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention