BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2920509 · Received January 17, 2013

    Report

    Report Number
    6000032-2013-00013
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    December 31, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495LZ25, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 7434A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3587A, LOT # LB9224, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATION. IT WAS STATED THAT THE PATIENT FELL RIGHT ON HIS IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2012. THE INS QUIT WORKING COMPLETELY AND THE PATIENT WHEN TO THE EMERGENCY ROOM AFTER THE FALL. THE HEALTH CARE PROVIDER WAS ABLE TO GET THE INS WORKING WITH THE CLINICIAN PROGRAMMER. THE PATIENT'S PAIN WAS WORSE IN HIS BACK AFTER THE FALL, AND HE HAD ISSUES WITH "DROP FOOT" AFTER THE FALL AS WELL. THE PATIENT HAD 3 DIFFERENT CT SCANS. IT WAS THOUGHT THAT THE PATIENT MIGHT HAVE HAD STENOSIS, BUT THAT WAS LATER REFUTED. IT WAS STATED THE PATIENT HAD SCAR TISSUE BUILD UP WHERE THE INS WAS LOCATED. THE INS WAS REPROGRAMMED "AROUND THE TIME OF THE FALL", BUT HAS HAD PAIN IN THE MIDDLE OF HIS BACK WHERE THE SCAR TISSUE WAS BUILT UP SINCE THE FALL. THE PATIENT WAS FEELING STIMULATION IN BOTH OF HIS LEGS, BUT WANTED IT REPROGRAMMED TO GET STIMULATION BETWEEN HIS SHOULDER BLADES. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013, BUT WAS IN SO MUCH PAIN HE DID NOT THINK HE COULD WAIT THAT LONG. IT WAS STATED THAT THE PATIENT WAS IN SO MUCH PAIN THAT IT WAS HARD TO BREATH. THE PATIENT WAS ONLY ABLE TO TURN STIMULATION UP OR DOWN AND HE COULD NOT SWITCH PROGRAMS. INCREASING OR DECREASING STIMULATION DID NOT HELP WITH THE WRONG LOCATION OF STIMULATION. AS OF (B)(6) THE PATIENT HAD NOT BEEN SEEN BY THE COMPANY REPRESENTATIVE FOR REPROGRAMMING. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD MET WITH A COMPANY REPRESENTATIVE AND THERE WERE PROGRAMMING ADJUSTMENTS MADE. IT WAS STATED THAT THE PATIENT REPORTED "HIS COVERAGE TO BE THE BEST HE'S HAD IN A LONG TIME". NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25632 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 00048 YR