BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3678278 · Received March 13, 2014

    Report

    Report Number
    3004209178-2014-04432
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Report Date
    February 21, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3550-39, LOT# N251848, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37092, LOT# 253500001, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PAINFUL STIMULATION FOR ABOUT THE PAST 6 MONTHS. IT WAS REPORTED THE PATIENT HAD BEEN IMPLANTED FOR STUMP PAIN AND IT HAD WORKED GREAT FOR YEARS, HOWEVER THE PATIENT ONLY FELT PAIN AT THE STUMP SITE WHEN STIMULATION WAS ON. IT WAS REPORTED THAT DURING A REPROGRAMMING SESSION THE PATIENT HAD NOT FELT ANYTHING UNTIL ABOUT "4V AMP" AND THEN SUDDENLY FELT PAIN. REPROGRAMMING WAS ATTEMPTED WITHOUT ANY PAIN REDUCTION. IT WAS NOTED THE USAGE SINCE (B)(6) 2012 HAD BEEN 1% (177 HOURS). IT WAS REPORTED IMPEDANCES WERE GOOD EXCEPT ELECTRODES 10 <(>&<)> 15 WHICH WERE GREATER THAN 10,000. IT WAS REPORTED THE PATIENT WAS PROGRAMMED TO 12+13-14-15+. IT WAS REPORTED ELECTRODE 15 WAS REMOVED WITHOUT CHANGE IN STIM. X-RAYS WERE PERFORMED WITH NO MIGRATION ISSUES. ADDITIONAL INFORMATION RECEIVED REPORTED THE PLAN WAS TO HAVE THE PATIENT RETURN TO THE CLINIC IN 2-4 WEEKS TO TRY REPROGRAMMING TO SEE IF THEY COULD HELP PAIN RATHER THAN AGGRAVATE IT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD BEEN REPROGRAMMED AT LOWER AMPLITUDES AND THE PATIENT DID HAVE COVERAGE IN PAINFUL AREAS. HOWEVER, STIMULATION DID SEEM TO TRIGGER PAIN EPISODES AGAIN. THE PATIENT WAS GOING TO TRY STIMULATION AT HOME AT A LOW AMPLITUDE AND KEEP A LOG. THE PATIENT WOULD FOLLOW UP AGAIN IN ONE MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151181 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR