BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1844817 · Received September 23, 2010

    Report

    Report Number
    3004209178-2010-07221
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    October 31, 2003
    Report Date
    May 20, 2019
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL TO UPDATE CODES, ALL PREVIOUS CODING IS BEING UPDATED, PREVIOUS CODING NO LONGER APPLIES.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT ON (B)(6) 2010, THAT THE THERAPY "DID NOT WORK PROPERLY" FOR THE PREVIOUS ONE TO ONE AND A HALF YEARS. THE PT STATED THAT THE LEADS "CAME LOOSE" FROM WHERE THEY WERE ATTACHED AND "WERE NEVER IN THE RIGHT PLACE." THE PT FELT SOME STIMULATION IN THE BACK OF A FOOT WHICH CAUSED THAT FOOT TO "DRAW UP." IT WAS LATER REPORTED THAT THE PT'S LAST VISIT TO SEE THE INITIAL PHYSICIAN WAS IN 2007. IT WAS NOTED, AT THAT TIME, THE PT REQUIRED A LEAD REVISION, BUT THE PT FAILED TO FOLLOW UP WITH THAT PHYSICIAN. THE PT WAS WORKING WITH A NEW PHYSICIAN IN (B)(6) 2010, AND A SPINAL CORD STIMULATOR (SCS) TRIAL WAS CONTEMPLATED. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT HE HAD STIMULATION IN AN UNDESIRED LOCATION. THE PATIENT STATED THAT AFTER STIMULATION MOVED TO AN UNDESIRED LOCATION HE ASSUMED IT WAS BECAUSE THE LEAD MOVED BUT IT WAS NOT CONFIRMED BY ANYONE. THE PATIENT TURNED STIMULATION OFF AND NEVER USED IT AGAIN. THE STIMULATION HAD MOVED FORM THE BACK OF THE HEEL TO THE UPPER PART OF THE HEEL NEAR THE ACHILLES AND HIGHER. THE CHANGE IN SYMPTOMS WAS CONSIDERED SUDDEN. THE PATIENT REPORTED THAT HE DOES NOT INTEND ON TRYING TO BE SEEN FOR THIS ISSUE AND WAS GOING TO SEE SOMEONE TO HAVE IT REMOVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON (B)(6) 2019. THE STIMULATOR NEVER HELPED WITH THEIR FOOT PAIN AND IT STOPPED WORKING ABOUT 10 YEARS AGO DUE TO REGULAR LONGEVITY. ABOUT 6 MONTHS AFTER IMPLANT, THE LEADS MOVED BUT THE PATIENT DIDN¿T WANT ANOTHER SURGERY BECAUSE AFTER PROGRAMMING SESSION IT DID NOT SEEM LIKE THE STIMULATOR WAS GOING TO HELP ANYWAYS. THE PATIENT HAD THEIR IMPLANT TAKEN OUT AND WANTED TO DISCUSS MRI OPTIONS. THE PATIENT HAD AN X-RAY ON (B)(6) 2019 AND THERE ARE 4 LITTLE WIRES IN THEIR ANKLE SO THEY ARE WONDERING IF THEY CAN HAVE AN MRI. THE PATIENT STATES THAT THE LEADS WERE PUT DOWN THEIR LEG TO HELP WITH FOOT PAIN. NO FURTHER COMPLICATIONS WERE REPORTED/ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MDT PUERTO RICO OPERATIONS CO 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention IMPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK027305V| PROGRAMMER: MODEL 7434A, LOT# NGL015381P| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: