BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3482434 · Received November 21, 2013

    Report

    Report Number
    3004209178-2013-21248
    Event Type
    Injury
    Date Received
    November 21, 2013
    Report Date
    November 7, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL # UNKNOWN, PRODUCT TYPE RECHARGER; PRODUCT ID 3982, SERIAL # (B)(4), IMPLANTED: (B)(6) 1995, PRODUCT TYPE LEAD; PRODUCT ID 377875, LOT # V011888, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3999, LOT # V008386, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 37742, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # UNKNOWN, PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT KEPT GETTING THE CHARGE THE RECHARGER ICON AND ALSO THE CHARGE THE NEUROSTIMULATOR ICON. IT WAS NOTED THAT THE PATIENT WAS ABLE TO GET TWO BLACK BOXES AND THEN IT CLICKED AND WENT TO A WARNING SCREEN. IT WAS NOTED THAT THE PATIENT CHECKED THE DEVICE WITH THE PATIENT PROGRAMMER AND THE IMPLANTABLE NEUROSTIMULATOR (INS) BOX WAS EMPTY. IT WAS NOTED THAT THE PATIENT STATED THAT THEY RECHARGED A WEEK AGO. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RECHARGER WAS NOT CHARGING. IT WAS NOTED THAT THE PATIENT HAD NOT CHARGED THE DEVICE FOR 3 MONTHS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT VISITED THEIR HEALTH CARE PROFESSIONAL (HCP) ABOUT THE EVENT. IT WAS NOTED THAT THE DEVICE WAS REPROGRAMMED SUCCESSFULLY. IT WAS NOTED THAT THE PATIENT PROGRAMMER WAS NOT REPLACED. IT WAS NOTED THAT THE RECHARGER WAS REPLACED. IT WAS NOTED THAT THE PATIENT COULD NOT RECHARGE SUCCESSFULLY. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS LOCATED IN THE FRONT. IT WAS NOTED THAT THE PATIENT HAD SURGERY TO FIX THE PROBLEM WITH THE SYSTEM ¿IN (B)(6) 2006.¿ IT WAS NOTED THAT THE PATIENT WOULD NOT HAVE SURGERY TO FIX THE PROBLEM. IT WAS NOTED THAT THE PATIENT STILL HAD PROBLEMS WITH THE SYSTEM. SEVERAL ATTEMPTS TO FOLLOW-UP FOR ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605817 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