BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4141061 · Received October 3, 2014

    Report

    Report Number
    3004209178-2014-18302
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    September 12, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377660, LOT# V000976, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 377660, LOT# V000976, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 377660, LOT# V000976, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 377660, LOT# V000976, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT SAW THE ELECTIVE REPLACEMENT INDICATOR (ERI) ON THEIR RECHARGER. THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT WAS WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE. AN APPOINTMENT DATE OF (B)(6) 2014 WAS NOTED. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD INCREASED PAIN AND WAS SEEN BY A COMPANY REPRESENTATIVE ON (B)(6) 2014. UPON INTERROGATION, IT WAS CONCLUDED THAT THE RIGHT SIDE LEAD WAS NON-FUNCTIONAL; THE PATIENT HAS HAD ISSUES WITH THE LEAD EVER SINCE THE IMPLANT TOOK PLACE NINE YEARS AGO AND HAS NEVER BEEN RIGHT. THE BATTERY DID NOT HAVE MUCH LIFE LEFT; THIS WAS NORMAL BATTERY DEPLETION BECAUSE IT WAS IMPLANTED NINE YEARS AGO. WHEN IMPEDANCES WERE CHECKED, ALL WERE HIGH. PRIOR TO THE COMPANY REPRESENTATIVE SEEING THE PATIENT, X-RAYS WERE DONE THAT SHOWED NO PROBLEMS; EVERYTHING WITH THE SPINAL CORD STIMULATION (SCS) DEVICE WAS INTACT AND APPEARED TO BE NORMAL. DID NOT FIND ANYTHING WRONG WITH THE PLACEMENT OR CONNECTIONS OF THE DEVICE AND LEADS. THE PATIENT¿S DOCTOR DECIDED THE WHOLE SYSTEM WILL BE REPLACED. NO REPLACEMENT DATE HAS BEEN DETERMINED YET. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618813 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention