BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2930752 · Received January 28, 2013

    Report

    Report Number
    6000032-2013-00022
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 7, 2013
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3888-28, LOT# L76873, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS HAVING PROBLEMS WITH STIMULATION AND IT WAS NOT TURNING ON PROPERLY. IT WAS NOTED THAT THE PATIENT WANTED TO MEET WITH A MANUFACTURER REPRESENTATIVE. EIGHT DAYS LATER, IT WAS REPORTED THAT THE PATIENT HAD HAD THE DEVICE FOR 12 YEARS AND THE BATTERY WAS DEAD. THE REPORTER STATED THAT THE PATIENT WAS IN EXCRUCIATING PAIN. THREE WEEKS LATER, IT WAS REPORTED THAT DURING IMPEDANCE TESTING AT DEFAULT SETTINGS, QUESTION MARKS WERE SHOWING UP IN THE RESULTS. IMPEDANCE TESTING WAS THEN DONE AT 3 VOLTS AND A PULSE WIDTH OF 450, WHICH SHOWED A SIGNIFICANT CHANGE IN IMPEDANCE RESULTS AND QUESTION MARKS WERE STILL BEING REPORTED. IT WAS NOTED THAT THE PATIENT WAS PREPARING TO HAVE THE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED. FIVE DAYS LATER, IT WAS REPORTED THAT NO FURTHER DIAGNOSTICS WERE PERFORMED AND NO MALFUNCTIONS WERE SEEN. THE REPORTER STATED THAT THERE WAS A PLANNED INS AND LEAD REPLACEMENT AND THE DEVICE WAS NOT BEING USED AT THE TIME. THREE WEEKS LATER, IT WAS REPORTED THAT THE INS WAS REPLACED AND THE PATIENT WAS GETTING COVERAGE IN THE AREAS HE PREVIOUSLY HAD COVERAGE. THE REPORTER STATED THAT ELECTRODE TWO ON THE LEAD HAD HIGH IMPEDANCE. THE DOCTOR DID NOT WISH TO REPLACE THE OLD LEAD AND AN ADAPTOR CONNECTED THE OLD EXTENSION TO THE NEW INS. THE PATIENT WAS PROGRAMMED AROUND ELECTRODE TWO. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36613 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