BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3072520 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06731
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    April 3, 2013
    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 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: RECHARGER: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POWER ON RESET CONDITION (POR) AND THE ERROR CODE WAS 0004. IT WAS FURTHER REPORTED THAT THE PATIENT HAD LEANED OVER 3 WEEKS PRIOR TO THE REPORT AND FELT A SHOCKING SENSATION IN A BACK/LEAD LOCATION TWICE. IT WAS NOTED THAT SINCE THE INITIAL OCCURRENCE THE PATIENT HAD BEEN EXPERIENCING THE SHOCKING 1-2 TIMES PER DAY. IT WAS ALSO NOTED THAT THE PATIENT'S THERAPY WAS WORKING WELL OTHERWISE. THE PATIENT HAD REPORTEDLY NOT BEEN SEEN BY THEIR HEALTH CARE PROVIDER (HCP) IN OVER A YEAR. IT WAS FURTHER NOTED THAT THERE WERE HIGH IMPEDANCE MEASUREMENTS ON ELECTRODES 4-7. HOWEVER, THIS LEAD WAS REPORTEDLY NOT BEING USED. THE LEAD THAT WAS IN USE SHOWED IMPEDANCES TO BE WITHIN NORMAL RANGE. IT WAS LATER REPORTED THAT THE MANUFACTURE REPRESENTATIVE WAS NOT AWARE OF WHAT CAUSED THE POR. THE POR WAS CLEARED AND THE PATIENT WAS INSTRUCTED TO CONTACT THEIR PHYSICIAN IF SHOCKING CONTINUES. IT WAS NOTED THAT THERE WAS NO PLAN TO REPLACE THE BATTERY OR LEADS AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD BENT THE OTHER WAY AND FELT THE "SHOCK AGAIN." IT WAS STATED THAT THE PATIENT HAD EVER SINCE THEN THE PATIENT HAD BEEN FEELING THAT SHOCKING SENSATION ABOUT ONCE OR TWICE A DAY, ALTHOUGH THE PATIENT"S "STIMULATION HAS BEEN JUST FINE." IT WAS REPORTED THAT THE MANUFACTURE REPRESENTATIVE SAW A POWER ON RESET (POR) WITH A SERVICE CODE OF "0X400" ON IT. IT WAS REPORTED THAT PATIENT DOES HAVE ONE FRACTURED ELECTRODE BUT IT WAS NOT BEING USED, IT HAD BEEN FRACTURED FOR A WHILE AND THERE HAD NEVER BEEN A PROBLEM WITH SHOCKING SENSATION. IT WAS REPORTED THAT IT HAD BEEN FRACTURED FOR AT LEAST OVER A YEAR. IT WAS REPORTED THAT IMPEDANCE ON ALL FOUR OF THE ELECTRODES WAS OVER 10,000. IMPEDANCE ON THAT UNUSED LEAD WAS CHECKED AT THE TIME OF REPORT AND WAS REPORTED AS GREATER THAN 40,000. IMPEDANCE WAS NORMAL ON THE LEAD THAT WAS BEING USED. IT WAS REPORTED THAT IT DID NOT MATTER WHAT POSITION THE PATIENT WOULD BE IN, THE SHOCKING SENSATION HAPPENED SPORADICALLY. IT WAS REPORTED THAT THE PATIENT HAD BEEN FALLING SOME BUT NOT A SPECIFIC ONE RIGHT BEFORE THE EVENT. IT WAS REPORTED THAT THE THERAPY ITSELF WAS WORKING AS INTENDED AND THE STIM WAS WORKING OKAY FOR THE PATIENT'S SYMPTOMS. IT WAS REPORTED THAT THE DEVICE HAD NOT HAD ANY OVERDISCHARGES OR PHYSICIAN MODE RECHARGES. IT WAS REPORTED THAT THE PATIENT FELT LIKE THE STIMULATION HAD BEEN ON THE ENTIRE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175339 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