BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 3790144 · Received May 5, 2014

    Report

    Report Number
    6000032-2014-00087
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-33, LOT# J0101882V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT NEVER THAT THERAPEUTIC EFFECT. IT WAS NOTED THAT A PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) NEVER WORKED CORRECTLY AND NEVER GAVE HER ANY PAIN RELIEF SINCE IMPLANT. THE REPORTER STATED THAT THE PATIENT¿S HEALTHCARE PROVIDER KNEW IT WASN¿T WORKING, TRIED MAKING ADJUSTMENTS, AND ¿TRIED EVERYTHING.¿ IT WAS REPORTED THAT WHEN THEY WERE MAKING ADJUSTMENTS IT ¿AUTOMATICALLY¿ SHOT PAIN DOWN THE PATIENT¿S LEGS. THE REPORTER STATED THAT THE HEALTHCARE PROVIDER NEVER EXPLAINED THE REASON WHY IT WASN¿T WORKING AND KEPT ADJUSTING AND CHANGING THE PATIENT¿S MEDICINE. IT WAS NOTED THAT WHEN THE SYSTEM WAS FIRST PUT IN THE PATIENT WEIGHED (B)(), SHE NOW WEIGHED (B)(6), AND THE INS WAS PROTRUDING OUT OF HER BUTTOCKS AND SHE COULDN¿T SIT DOWN. THE PATIENT WAS IN PAIN CONSTANTLY BECAUSE THE DEVICE NEVER HELPED HER AND SHE TOOK ¿TOO MUCH¿ TYLENOL AND ADVIL. IT WAS REPORTED THAT THE PATIENT COULDN¿T WORK BECAUSE SHE COULDN¿T LIFT A LOAD AND SHE HAD A HARD TIME FINDING A JOB BECAUSE ¿NOBODY HIRES WITH THE IMPLANT BECAUSE OF THE CHANCES OF HURTING YOUR BACK.¿ IT WAS UNCLEAR WHAT THIS REFERRED TO. IT WAS NOTED THAT THE DEVICE SYSTEM RAN UP THE PATIENT¿S SPINE, ALMOST TO THE BASE OF HER NECK, AND BACK DOWN AGAIN. IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS THAT STIMULATION WAS IRRITATING AND THE ISSUE RELATED TO THE INS WAS THAT THE PATIENT LOST A LOT OF WEIGHT AND THE INS WAS PROTRUDING. IT WAS UNKNOWN IF THE ISSUE WAS DUE TO THE LEAD OR EXTENSION. IT WAS NOTED THAT THE PATIENT HAD BEEN REPROGRAMMED SEVERAL TIMES, NEVER GOT GOOD PAIN RELIEF, AND DIDN¿T LIKE THE FEELING. SIGNS AND SYMPTOMS ASSOCIATED WITH THE EVENT INCLUDED AN UNCOMFORTABLE INS. IT WAS REPORTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267070 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR