BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3409747 · Received October 15, 2013

    Report

    Report Number
    3004209178-2013-19099
    Event Type
    Injury
    Date Received
    October 15, 2013
    Date of Event
    May 2, 2013
    Report Date
    September 23, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-45, LOT# V804748, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT# V882270, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATION TURNS UP ON ITS OWN. THE PATIENT WOULD BE AT 5.5 VOLTS AND LATER THEY WOULD BE AT 7.5 VOLTS. PATIENT DID NOTE THEY HAD ADAPTIVE STIMULATION. PATIENT NOTED THEY WERE HAVING A SURGICAL PROCEDURE TO HAVE AN ADDITIONAL LEAD INSERTED. THE PATIENT WAS UNCLEAR ABOUT WHAT EXACTLY WAS HAPPENING. THE PATIENT DID NOTE THE NUMBER 7 ELECTRODE WAS ¿OUT OF COMMISSION.¿ THE PATIENT ALSO NOTED ¿18 LEADS IN THEIR BODY.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528175 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention