BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 2994263 · Received March 8, 2013

    Report

    Report Number
    3004209178-2013-03479
    Event Type
    Injury
    Date Received
    March 8, 2013
    Report Date
    May 29, 2013
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, NEU_UNKNOWN_PROG LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID, NEU_UNKNOWN_LEAD LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 748951 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE REVISION HAD NOT YET HAPPENED. IT HAD BEEN SCHEDULED FOR (B)(6) 2013 BUT THE PATIENT HAD NOT RECEIVED CARDIAC CLEARANCE. IT WAS REPORTED THE PATIENT RECEIVED CARDIAC CLEARANCE AND WAS SCHEDULED FOR SURGERY ON (B)(6) 2013. IT WAS LATER REPORTED THE SURGERY WAS CANCELLED. SURGERY WAS RESCHEDULED FOR (B)(6) 2013. IT WAS LATER REPORTED THE SURGERY WAS POSTPONED AGAIN DUE TO A NUMBER OF FACTORS INCLUDING THE PATIENT COMPLAINING OF "NEW PAIN" IN THEIR LEFT LEG. THE HEALTH CARE PROFESSIONAL DEEMED IT MEDICALLY NECESSARY TO REPLACE THE PATIENT'S CURRENT SYSTEM WITH A RESTORE FAMILY DEVICE AND TWO LEADS IN LIGHT OF THE PATIENT'S BILATERAL PAIN PATTERN. IT WAS NOTED THIS WOULD HAVE TO BE DONE AT ANOTHER FACILITY. CT WAS ORDERED TO DIAGNOSE THE NEW PAIN AND FOLLOWING THAT THE REPLACEMENT WILL BE SCHEDULED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT¿S INS AND EXTENSION WERE EXPLANTED AND A NEW LEAD PLACED. A NEW INS WAS THEN CONNECTED TO THE LEAD. IT WAS REPORTED THAT THE PATIENT HAD EFFECTIVE PARATHESIA AND WAS ¿VERY PLEASED¿ WITH THEIR NEW SYSTEM. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013 THAT THE PATIENT HAD LOST STIMULATION "A WHILE AGO" AFTER HE HAD STRETCHED. IT WAS STATED THAT THE PATIENT SAID HIS IMPLANTABLE NEUROSTIMULATOR (INS) "WAS DEAD FOR ABOUT A MONTH" AND WAS TAKING PAIN PILLS BECAUSE HE WAS IN PAIN. IT WAS ALSO STATED, THE INS WAS CHECKED ON (B)(4) 2012 AND READ "OK". IT WAS THEN REPORTED ON (B)(6) 2013 THAT THE REPRESENTATIVE SAW THAT THE BATTERY WAS REPLACED IN 2008, AND A REVISION WAS SCHEDULED FOR "AROUND" (B)(6) 2013. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE PATIENT WAS SCHEDULED TO HAVE REVISION SURGERY ON (B)(6) 2013. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98554 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 Required Intervention