BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 3172458 · Received June 17, 2013

    Report

    Report Number
    6000032-2013-00153
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 28, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7496-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1995, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3982, SERIAL# (B)(4), IMPLANTED: (B)(6) 1995, PRODUCT TYPE: LEAD. PRODUCT ID 7434A, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID 3982, SERIAL# (B)(4), IMPLANTED:(B)(6) 1995, PRODUCT TYPE LEAD. PRODUCT ID 7496-51, SERIAL# (B)(4), IMPLANTED: (B)(6)1995 PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THIS OCCURRED SIX MONTHS AGO WHEN THE PATIENT LAST FELT THE STIMULATION WORKING. IT WAS NOTED THAT THE PATIENT WAS UNABLE TO TURN STIMULATION ON WITH THE PATIENT PROGRAMMER. IT WAS NOTED THAT THE PATIENT REPORTED GETTING GOOD STIMULATION IN THE TARGET AREA OF BOTH LEGS BEFORE THE STIMULATION QUIT. IT WAS NOTED THAT THE PATIENT DID NOT REPORT ANY STIMULATION WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED ON USING A PHYSICIAN PROGRAMMER; HOWEVER, IT WAS LATER REALIZED THAT THE VOLTAGE WAS STILL AT 0 VOLTS WHEN IT WAS TURNED ON, SO IT WAS NOT CLEAR YET IF THE PATIENT COULD FEEL STIMULATION. IT WAS NOTED THAT THE PHYSICIAN PROGRAMMER SHOWED THE INS HAD RESET AND THERE WAS NO STIMULATION USE SHOWING. IT WAS NOTED THAT THE BATTERY WAS SHOWING OK BUT THE LONGEVITY WAS DISPLAYING QUESTION MARKS. IT WAS REPORTED THAT THE REPORTER WAS GETTING QUESTION MARKS IN THE IMPEDANCE RESULTS. IT WAS NOTED THAT A SECOND IMPEDANCE TEST WAS PERFORMED AT A HIGHER VOLTAGE OF 2 VOLTS AND THE IMPEDANCE RESULTS WERE NORMAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT¿S BATTERY WAS REPLACED. IT WAS NOTED HE WAS ¿DOING GREAT¿ AT THE TIME OF REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED ¿THERE WERE NO DEVICE MALFUNCTIONS IDENTIFIED OTHER THAN THE INS RESET.¿ IT WAS NOTED THE PATIENT WAS SCHEDULED FOR A BATTERY REPLACEMENT ON 2013-(B)(6). IT WAS FURTHER REPORTED THE PATIENT¿S REPLACEMENT WAS TO BE RESCHEDULED DUE TO THEIR INSURANCE. A NEW REPLACEMENT DATE WAS UNKNOWN AT THE TIME OF REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FOUND IT WAS FURTHER REPORTED A POWER ON RESET (POR) HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274065 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 00060 YR Required Intervention