BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 7801832 · Received August 21, 2018

    Report

    Report Number
    3004209178-2018-18756
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    September 21, 2016
    Report Date
    August 21, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3587A25, LOT# N230421, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3587A25, SERIAL/LOT #: N230421, (B)(6), (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE INS WAS NO LONGER FUNCTIONAL AND WAS NOT HELPING WITH HIS PAIN WHERE IT WAS LOCATED. THE PATIENT MADE THE DECISION TO HAVE THE INS EXPLANTED. THE ELECTRODES WERE CUT FROM THE GENERATOR. THE HCP MADE THE DECISION TO LEAVE THE PADDLE LEAVE IMPLANTED BECAUSE IT WAS ADHERED TO STRONGLY TO THE DURA. THE HCP DIDN¿T WANT TO RISK TEARING THE FASCIA. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642146 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention