BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2731493 · Received September 6, 2012

    Report

    Report Number
    3004209178-2012-07843
    Event Type
    Injury
    Date Received
    September 6, 2012
    Report Date
    August 9, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3777-60, SERIAL#: (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE: LEAD PRODUCT ID: 3777, LOT#: V949 991012, IMPLANTED: 2012-(B)(6), PRODUCT TYPE: LEAD PRODUCT ID: 37754, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER PRODUCT ID: 37744, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE LEADS DID NOT 'CLOSE UP PROPERLY.' IT WAS PLANNED THAT THE LEAD WOULD BE REMOVED AND THEN REVISED AT A LATER DATE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING 'GREAT.' IF ANY ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE INCLUDED IN A SUPPLEMENTAL 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