BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4122571 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17817
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED:(B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT THAT HAD STARTED ¿SEVERAL MONTHS TO A YEAR AGO.¿ THE PATIENT DID NOT KNOW IF THE LOSS OF THERAPEUTIC EFFECT HAD BEEN SUDDEN OR GRADUAL. THE PATIENT HAD MET WITH A MANUFACTURER REPRESENTATIVE TO HAVE THE DEVICE REPROGRAMMED, BUT THE ISSUES HAD CONTINUED. THE PATIENT HAD TRIED ¿INJECTIONS¿ AND HAD HAD A MYELOGRAM. THE PATIENT LATER HAD A SURGERY DONE TO REPLACE THE SYSTEM AS THE PATIENT¿S NERVES WERE BEING COMPRESSED AND THE PATIENT HAD A SPINAL STENOSIS. THE PATIENT WAS THEN KEPT IN THE HOSPITAL OVER THE WEEKEND AFTER THE BACK SURGERY.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THEY HAD NO CONCERNS WITH THEIR DEVICE THERAPY. THE PATIENT ALSO REPORTED THAT THEY RECEIVED ASSISTANCE FROM THEIR DOCTOR AND THEIR CONCERNS WERE RESOLVED. AN APPOINTMENT OF (B)(6) 2014 WAS NOTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601018 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 00067 YR Hospitalization| R