BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2854672 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11069
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 6, 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
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN APPROVED FOR A REVISION DUE TO "A LEAD BEING IN THE UPPER SHOULDER." THE PATIENT HAD EXPERIENCED A BURNING SENSATION WHEN RECHARGING HIS DEVICE. THE PATIENT STATED THAT HE HAD EXPERIENCED STIMULATION ONE MONTH AGO, AND THE LAST SUCCESSFUL RECHARGING SESSION OCCURRED ONE MONTH AGO. AN OVERDISCHARGE WAS SUSPECTED, AND THE ANTENNA LOCATE FEATURE WAS UTILIZED IN DETERMINING THAT A POWER ON RESET (POR) HAD OCCURRED. THE RECHARGER THEN DISPLAYED A NORMAL RECHARGING SCREEN. THE PATIENT STATED HE STILL HAD DIFFICULTY WITH TEMPERATURE AND MENTIONED THAT HE NEEDED TO BE CAREFUL SO HE "DOES NOT GET BURNED." THE PATIENT ALSO REPORTED THAT THERE WAS SWELLING WHERE THE WIRES WERE, AND THAT THAT HAD BEEN ONGOING. THE PATIENT STATED THAT HE NEEDED MORE THAN 16 ELECTRODES AND INQUIRED IF THERE "WAS ANYTHING OUT THERE." THE PATIENT STATED THAT HE HATED RECHARGING. THE PATIENT HAD VOLUNTARILY DETOXED FROM ORAL MEDICATIONS WHICH WAS THOUGHT TO BE RELATED TO "PERSONAL FAMILY ISSUES." IT WAS UNCLEAR IF THE PATIENT HAD "WEANED OFF ORAL MEDICATIONS" FOR THIS OR OTHER REASONS. NO FURTHER INFORMATION WAS REPORTED AT THE TIME OF THIS SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention