BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4925605 · Received July 20, 2015

    Report

    Report Number
    3004209178-2015-13668
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    March 30, 2015
    Report Date
    June 23, 2015
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3487A-56, LOT# V012591, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# J0519278V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377875, LOT# V008373, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP INDICATING THAT THE CLINICIAN PROGRAMMER WAS NOT DISPLAYING THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE AS WOULD BE EXPECTED. THE PATIENT HAD BEEN IMPLANTED FOR 8 YEARS 8 MONTHS. THE HCP DID NOT KNOW IF THE PATIENT WAS SEEING THE ERI MESSAGES ON THE PROGRAMMER OR RECHARGER. THE BATTERY SECTION OF THE CLINICIAN PROGRAMMER DISPLAYED THE BATTERY ICON AND OK STATUS. IT WAS NOTED THAT FROM THE LAST INTERROGATION REPORT, IT INDICATED THAT THE ONLY ABNORMAL OBSERVATION WAS THE CHECK IMPLANTABLE NEUROSTIMULATOR (INS) CLOCK. IT WAS ADVISED THAT THE HCP CONFIRM WITH THE PATIENT IF THEY WERE SEEING ERI ON THEIR EXTERNAL DEVICES. NO SYMPTOMS WERE REPORTED. THE EVENT DATE WAS (B)(6) 2015. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PATIENT'S HEALTH CARE PROVIDER (HCP) WAS SEEING "INVALID SETTINGS CODE 49, ALL SETTING WILL BE CLEARED 0:0" ON THE CLINICIAN PROGRAMMER (8840) WHEN INTERROGATING THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT HAS NOT BEEN USING THE SYSTEM, JUST CHARGING IT. THE INS STOPPED HELPING THE PATIENT ON (B)(6) 2015. THE PATIENT EXPERIENCED LOW BACK PAIN AND BILATERAL L4 RADICULAR PAIN. THE HCP HAD NO FURTHER INFORMATION OF WHY THE DEVICE DOES NOT HELP THE PATIENT. THE HCP STARTED THE PATIENT ON MEDICATIONS OF METHADONE, FENTANYL, AND GABAPENTIN ON (B)(6) 2015 TO RESOLVE THE LACK OF THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470033 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 00061 YR