BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 7915737 · Received September 27, 2018

    Report

    Report Number
    3004209178-2018-21721
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Report Date
    September 27, 2018
    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
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-45, LOT# V123646, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V229123, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V229123, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V184882, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3888-45, SERIAL/LOT #: (B)(4), UBD: 06-JUN-2012, UDI#: (B)(4); PRODUCT ID: 3888-45, SERIAL/LOT #: (B)(4), UBD: 20-MAR-2013, UDI#: (B)(4); PRODUCT ID: 3888-45, SERIAL/LOT #: (B)(4), UBD: 20-MAR-2013, UDI#: (B)(4) ; PRODUCT ID: 3888-45, SERIAL/LOT #: (B)(4), UBD: 04-DEC-2012, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT THE PATIENT¿S MACHINE WAS NOT WORKING. THE PATIENT WAS NOT SURE IF IT WAS THE IMPLANT THAT WAS NOT WORKING. THE PATIENT WAS IMPLANTED IN 2009 AND FELL ABOUT 5 YEARS PRIOR TO THE REPORT ON CONCRETE. SINCE SHE FELL, 2 OUT OF THE 4 LEADS THAT SHE HAD IMPLANTED ¿STOPPED WORKING.¿ THE PATIENT THOUGHT THAT THOSE TWO LEADS HAD BECOME DISLODGED OR BROKEN. IN THE LAST SEVERAL MONTHS (CONFIRMED AS STARTING IN 2018), THE PAIN HAS BEEN PRETTY BAD. SHE JUST WANTS TO GET EVERYTHING FIXED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755276 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