BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 3684296 · Received March 18, 2014

    Report

    Report Number
    3004209178-2014-04542
    Event Type
    Injury
    Date Received
    March 18, 2014
    Report Date
    February 21, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3888-28, LOT# L51520, IMPLANTED: (B)(6) 1998, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD STIMULATION IN THE WRONG LOCATION AND A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD A LAMINECTOMY OF L2, L3, AND L4 IN (B)(6) 2014 AND AFTERWARDS THE PATIENT¿S STIMULATION HAD NOT BEEN THE SAME. THE PATIENT WAS GETTING EFFECTIVE THERAPY BEFORE THE SURGERY AND IT WAS IN THEIR BACK. AFTER THE SURGERY, THE STIMULATION STARTED IN THE PATIENT¿S TOES AND BY THE TIME THE STIMULATION REACHED THE PATIENT¿S BACK IT WAS TOO STRONG. DURING A REPROGRAMMING ON THE DAY OF THE REPORT, THE PATIENT WASN¿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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT HAPPENED DURING THE REPROGRAMMING OF THE SPINAL CORD STIMULATOR (SCS). IT WAS NOTED THAT IT WAS UNKNOWN WHAT DEVICES THE EVENT WAS ATTRIBUTED TO. IT WAS NOTED THAT THE EVENT WAS PROBABLY DUE TO THE LEAD OR THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT SURGICAL INTERVENTION WAS STILL TO BE SCHEDULED. IT WAS NOTED THAT REPROGRAMMING WAS NOT POSSIBLE DUE TO QUESTIONABLE DEVICES. IT WAS NOTED THAT A REVISION WAS PENDING. IT WAS NOTED THAT PATIENT HOSPITALIZATION WAS NOT REQUIRED DUE TO THE EVENT. IT WAS NOTED THAT THE PATIENT WAS REFERRED TO A NEUROSURGEON FOR AN EVALUATION TO REPLACE THE UNIT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LAST THE MANUFACTURING REPRESENTATIVE HAD HEARD THE PATIENT WAS WAITING TO GET SCHEDULED FOR A CONSULT WITH THE DOCTOR. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158050 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 00071 YR Required Intervention