BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3041460 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04879
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 22, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37751, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 377875, LOT # J0555561V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 377875, LOT # J0555561V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WAS CHARGING "MORE THAN EXPECTED." THE PATIENT REPORTEDLY LOST 100 POUNDS AND STATED THAT THE POCKET AREA WAS "A LITTLE UNCOMFORTABLE." IT WAS NOTED THAT THE PATIENT HAD TO CHARGE "ABOUT ONCE PER WEEK" AND IMPEDANCES WERE "WITHIN NORMAL RANGE." IT WAS STATED THAT THE RECHARGE ESTIMATE BASED ON CURRENT SETTING BATTERY "SHOULD GO FROM FULL TO EMPTY IN APPROXIMATELY 27 WEEKS AND LOW IN 17 WEEKS." THE PATIENT REPORTEDLY "ONLY USED STIMULATION FOR ABOUT 2 HOURS A DAY." IT WAS NOTED THAT THE PATIENT WAS SUPPLIED WITH A DIFFERENT RECHARGER SO THAT DETAILED RECHARGE STATISTICS COULD BE OBTAINED AND REVIEWED. LESS THAN TWO MONTHS LATER, IT WAS REPORTED THAT THE PATIENT'S BATTERY WAS REMOVED AND REPLACED WITH A SENSOR. IT WAS STATED THAT THE PATIENT WANTED A POCKET REVISION AND THE PHYSICIAN DISCUSSED REPLACING HER BATTERY. IT WAS NOTED THAT BOTH THE PHYSICIAN AND THE PATIENT "AGREED TO PROCEED WITH THE BATTERY REPLACEMENT AND POCKET REVISION." IT WAS NOTED THAT THE ADAPTIVE STIMULATION WAS SET UP ON THE DAY OF THE REPORT AND THE PATIENT WAS "VERY PLEASED WITH THIS FEATURE." A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143790 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention