BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3923633 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12750
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 20, 2014
    Report Date
    August 9, 2016
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3776-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3776-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3550-39, LOT # N231542, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37092, LOT # 228530001, # IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PAIN AND BURNING SENSATION AT THE POCKET SITE. IT WAS NOTED THE STIMULATOR WAS TOO SHALLOW. IT WAS REPORTED THE STIMULATOR WAS REPOSITIONED AND IMPLANTED DEEPER. IT WAS NOTED THE PATIENT HAD A LAP-BAND PROCEDURE AND LOST WEIGHT PRIOR TO REVISION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT SHE HAD LOST A BUNCH OF WEIGHT OVER THE COURSE OF 10 MONTHS AND THE IMPLANT BECAME LOOSE IN THE POCKET. THE PATIENT HAD A REVISION IN (B)(6) 2011. THE INDICATION FOR USE WAS LUMBAR RADICULOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399893 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 00045 YR Required Intervention