BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3811319 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08992
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 24, 2014
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 355531, LOT# N323569, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 3550-39, LOT# N313685, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS SHOWING >10,000 OHMS. THE PATIENT FELT A STRANGE SENSATION FOR SEVERAL HOURS EVEN AFTER THEIR STIMULATION WAS TURNED OFF. IMPEDANCE TESTING AT 0.7V REFLECTED ALL CONTACTS AT >10,000. THE IMPEDANCE TEST COULD NOT BE RUN AT 1.5V BECAUSE THE PATIENT COULD NOT HANDLE THE STIMULATION AT 1.5V. THE PATIENT¿S STIMULATION WAS SET AT 2-, 3-, 10+, 11+ WITH A ¿660¿ PULSE WIDTH AND A 40 HZ RATE. THE AMPLITUDE WAS SET AT 0.85 VOLTS. THE PATIENT WAS GETTING GOOD THERAPY AND THERE WAS IT WAS IN AN APPROPRIATE COVERAGE PATTERN. A GROUP IMPEDANCE WAS DONE AND IT SHOWED 365 AND 2.254 MA. CHANGING THE PULSE WIDTH TO 120 REFLECTED A 367 IMPEDANCE. THE LOW IMPEDANCE COULD BE DUE TO THE NORMAL DRAW ON THE SYSTEM. IT WAS FURTHER REPORTED THAT THE PATIENT SHUT THEIR STIMULATION OFF AFTER LEAVING THE MEETING WITH THE MANUFACTURER REPRESENTATIVE. THEY FELT THE NORMAL RESIDUAL EFFECT FOR ABOUT 30 MINUTES. THE PATIENT¿S ¿REGULAR¿ RADICULAR PAIN WAS FELT, INCREASING IN SEVERITY, AS THE RESIDUAL EFFECTS WORE OFF. THE PATIENT WAS ABLE TO FEEL A LOW INTENSITY ¿STIMULATION¿ FEELING OVER THEIR ARM PAIN. THEY ESPECIALLY FELT THIS SENSATION WHEN LYING DOWN AND WITH CERTAIN OTHER HEAD POSITIONS. IT FELT DIFFERENT THAN THE TINGLING AND ALTERED SENSATION THAT THEY WOULD NORMALLY HAVE. THESE SENSATIONS ALONG WITH THE IMPEDANCE READINGS ON THE MACHINE MADE THE PATIENT LEAN TOWARDS HAVING A REVISION SURGERY. THE PATIENT¿S RIGHT ARM WAS GETTING WORSE SO BEING ABLE TO HAVE LEADS ARRANGED TO HELP BOTH SIDES AND GETTING AN MRI COMPATIBLE DEVICE APPEALED TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD A REVISION/REPLACEMENT SURGERY TWO WEEKS PRIOR TO THE REPORT AND A SECOND FULL SYSTEM WAS IMPLANTED. THE PROBLEM WITH THE ORIGINAL SYSTEM WAS THAT THERE WERE POOR IMPEDANCES AT THE EXTENSIONS. THEY WERE REPLACED AND THE PATIENT GOT AN UPGRADED BATTERY. A SECOND SYSTEM WITH PERCUTANEOUS LEADS WAS ALSO IMPLANTED. THE PATIENT WAS GETTING EXCELLENT COVERAGE WITH BOTH SYSTEMS AND HAD FULL FUNCTION WITH NO IMPEDANCE ISSUES OR STRANGE SENSATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290735 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention