BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4111249 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17576
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 2, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 377860, LOT# V003662, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 377860, LOT# V003662, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS STIMULATOR NO LONGER WORKED AND HADN¿T FOR 4-5 YEARS. THE PHYSICIAN THAT IMPLANTED IT WAS REFUSING TO REMOVE IT AS THE PATIENT DID NOT WORK WITH THE PHYSICIAN ANY LONGER. THE PATIENT NEEDED IT REMOVED AS HE WAS TOLD BY AN ACUPUNCTURIST (ABOUT A MONTH PRIOR) THAT IT WAS SITTING RIGHT ON A SCIATIC NERVE. THE PATIENT HAD CANCER AND HAD LOST A LOT OF WEIGHT. THE SCIATIC NERVE HAD BEEN GIVING HIM A LOT OF TROUBLE; THE PATIENT STATED IT WAS PROBABLY BECAUSE THE DEVICE WAS SITTING RIGHT ON TOP OF THE NERVE. THE PATIENT WAS GIVEN PHYSICIAN LISTINGS. ABOUT 2 WEEKS LATER, THE PATIENT REPORTED HE HAD CALLED ALL THE PHYSICIANS ON THE LISTING BUT HAD NO LUCK FINDING SOMEONE TO TAKE IT OUT (INSURANCE AND/OR DISTANCE ISSUES). THE PATIENT FELT THAT HE WAS GOING TO HURT FOR THE REST OF HIS LIFE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PATIENT¿S PHYSICIAN REGARDING THE OUTCOME. IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT. OF NOTE, PER THE REGISTRATION SYSTEM, THE PATIENT HAD BILATERAL ACTIVE DEVICES. MDRS WERE SENT FOR BOTH DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590646 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR