BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3001729 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03625
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 20, 2013
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT# V027462, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-29, LOT# N142182, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATED THAT ONE OF THE LEADS HAD BEEN 'FAULTY' SINCE IT WAS IMPLANTED. IT WAS NOTED THAT THE PATIENT LACKED STIMULATION ON THEIR LEFT SIDE, WHICH WAS WHERE PAIN RELIEF WAS NEEDED THE MOST. THE PATIENT STATED THAT 'THE PAIN HAS GOTTEN WORSE GRADUALLY OVER THE LAST FEW YEARS.' IT WAS STATED BY THE PATIENT THAT HER 'DEGENERATIVE DISC DISEASE WAS PUTTING PRESSURE ON HER NERVES.' IT WAS STATED THAT THE PATIENT HAD BEEN TRYING TO SCHEDULE A REPROGRAMMING APPOINTMENT AT THEIR DOCTOR'S OFFICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105932 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