BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3132749 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08299
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 6, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS FURTHER REPORTED THAT THE PATIENT HAD THEIR DEVICE REMOVED THE WEEK PRIOR TO THE REPORT BECAUSE IT ¿NEVER WORKED.¿ IT WAS NOTED THAT THE PATIENT NEEDED AN MRI BECAUSE SHE HAS NEUROPATHY AND THEY ¿NEEDED TO FIGURE OUT WHY HER LEGS ARE PARALYZING.¿ IT WAS LATER REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURE REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS NOTED THAT THE PATIENT HAD APPOINTMENTS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236916 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 Required Intervention