BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2895457 · Received January 3, 2013

    Report

    Report Number
    3007566237-2013-00028
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 748925, 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: 3888-33, LOT#: J0444112V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO STIMULATION SENSATION POST-OPERATIVELY FOLLOWING A DEVICE REPLACEMENT. ELECTRODES 0-3 WERE PROGRAMMED AND IMPEDANCES RANGED FROM 2200-5500 WITH 0 AS A REFERENCE. IT WAS UNKNOWN IF A CONDUCTIVE SOLUTION WAS USED TO IRRIGATE THE DEVICE IN THE OPERATING ROOM. IT WAS REPORTED THAT THE DEVICE WAS GOING TO BE REPROGRAMMED AND THEY WERE GOING TO TURN IT OFF UNTIL THE FOLLOWING DAY AND TRY AGAIN. IT WAS NOTED THAT IF THE ISSUE WAS DUE TO CONDUCTIVE FLUID IT WOULD ABSORB AND THE DEVICE SHOULD BE ABLE TO GET STIMULATION THE NEXT DAY. SIX DAYS LATER IT WAS REPORTED THAT THE PATIENT HADN'T USED STIMULATION IN OVER THREE YEARS, AND THE PATIENT JUST HAD THE DEVICE REPLACED. IT WAS NOTED THAT CURRENT IMPEDANCE MEASUREMENTS WERE SLIGHTLY ELEVATED. TWO DAYS LATER, IT WAS REPORTED THAT AN X-RAY HAD BEEN ORDERED AND NO MALFUNCTIONS HAD BEEN SEEN. THERE WAS NO CHANGE TO THE PATIENT'S THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE HIS SYSTEM REVISED ON (B)(6)-2013. THE X-RAYS TAKEN 'LOOKED FINE'. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS SCHEDULED FOR A REVISION PROCEDURE THE NEXT DAY IN RELATION TO THE ABSENCE OF STIMULATION SENSATION. IT WAS STATED THAT DURING THE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT, AN ADAPTOR WAS INTRODUCED. IMPEDANCES HAD BEEN NORMAL AT THAT TIME AND WERE STILL NORMAL. HEALTHCARE PROFESSIONAL (HCP) WOULD BE DOING EXPLORATORY PROCEDURE THE NEXT DAY. MORE THAN ONE WEEK LATER IT WAS STATED THAT THE PROCEDURE DID NOT HAPPEN AND THAT THE PATIENT WAS BEING RESCHEDULED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE THE REVISION SURGERY ON (B)(6) 2013. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SUCCESSFULLY REVISED ON (B)(6) 2013. HIS LEAD WAS REMOVED AND TWO NEW LEADS WERE IMPLANTED. FOLLOWING THE PROCEDURE THE PATIENT WAS RECEIVING VERY GOOD STIMULATION AND PAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2630 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention