BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2841865 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10620
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 24, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2012 (B)(6), 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 THE PATIENT HAD HER ENTIRE SYSTEM EXPLANTED BECAUSE IT WAS TOO DIFFICULT TO OPERATE, AND STIMULATION WAS IN THE WRONG PLACES. THE PATIENT STATED THAT SHE HAD NEVER HAD THERAPEUTIC EFFECT. NO PATIENT SYMPTOMS OR INJURIES WERE KNOWN TO BE RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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