BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2961607 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02637
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 25, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS STATED THAT PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS CURRENTLY NOT FUNCTIONING. THE DEVICE WAS IMPLANTED TO TREAT THE PAIN IN HER BACK BUT SHE WAS NEVER ABLE TO FEEL THE STIMULATION THERE, SHE ONLY FELT IT IN HER LEGS. THE PATIENT HAD BEEN TOLD THAT THE LEADS WEREN'T PLACED CORRECTLY. IT WAS STATED THAT THE NEXT TIME THE PATIENT HAD BACK SURGERY SHE WAS GOING TO HAVE THE DEVICE TAKEN OUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64366 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1