BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2914107 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00548
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 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 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL #(B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3708120, SERIAL# (B)(4), EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD HER IMPLANTABLE NEUROSTIMULATOR REVISED ON (B)(6) 2012 DUE TO THE DEVICE PROTRUDING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS DETERMINED TO BE NOT RELATED TO THE DEVICE. THE BATTERY WAS FALLING OUT OF PLACE WHICH WAS AFFECTING STIMULATION. AN X-RAY REVEALED THE BATTERY HAD SHIFTED IN POSITION. AS A RESULT THERE WAS A GRADUAL LOSS OF THERAPEUTIC EFFECT. THE BATTERY WAS MOVED FROM THE LEFT FLANK TO THE RIGHT BUTTOCK AND THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT AND HAD GREATER THAN 50% THERAPY RELIEF.

    Description of Event or Problem · 1

    THE PATIENT INDICATED THAT THE IMPLANT WAS IMPLANTED SIDEWAYS IN 2012. ON (B)(6) 2012 IT WAS REVISED AND MOVED TO HER WAIST. THE PATIENT SAID IT WAS SUPPOSED TO HAVE BEEN MOVED TO HER BUTTOCKS (REFER TO REPORT # 3004209178-2014-20008). REFER TO MANUFACTURER'S REPORT # 3004209178-2014-20008 FOR THE PATIENT¿S NEXT REVISION IN 2014 RELATED TO THE IMPLANT BEING MOVED TO THE BUTTOCKS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S DEVICE WAS REVISED DUE TO THE DEVICE BEING ¿SIDEWAYS AND PROTRUDING¿ IT WAS MADE FLUSH. NOTE: THIS EVENT WAS UPDATED TO COMPLY WITH CURRENT CODING CONVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20659 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