BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3173676 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10459
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 28, 2013
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4). IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4) IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A DEPLETED BATTERY. IT WAS STATED THAT BECAUSE OF THE PATIENT'S HEALTH, LOSS OF MOBILITY, AND WEIGHT GAIN, IT HAD BECOME DIFFICULT FOR HER TO RECHARGE HER BATTER. THEREFORE, A REPLACEMENT OF THE BATTERY WAS PERFORMED. IT WAS STATED THAT THERE WERE "NO SIGNS OR SYMPTOMS". IT WAS NOTED THAT AN EXAMINATION AND PALPITATION OF THE AREA HAD HAPPENED ON (B)(6) 2012 AND THAT WAS WHEN IT WAS DECIDED THAT IT WAS NECESSARY TO REVISE THE BATTERY. THE SURGICAL REPOSITIONING HAPPENED ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAD PHYSICAL DIFFICULTIES WITH RECHARGING AND WAS UNABLE TO RECHARGE. THE PATIENT NEEDED TO CHANGE TO A NON-RECHARGEABLE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273033 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 00068 YR Required Intervention