BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2842934 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10688
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 26, 2012
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), PRODUCT TYPE LEAD, PRODUCT ID 3778-60, SERIAL# (B)(4), 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 PATIENT HAD IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED BECAUSE THE STIMULATION WAS IN THE WRONG AREA. INS DISCHARGER AND RECHARGER WAS NOT RESPONSIVE. PATIENT STATED THAT NEW SYSTEM WORKS WONDERFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention