BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3057334 · Received April 15, 2013

    Report

    Report Number
    3004209178-2013-06221
    Event Type
    Injury
    Date Received
    April 15, 2013
    Report Date
    March 21, 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

    CORRECTION: THE PREVIOUS REPORT SHOULD NOT HAVE BEEN SENT. THE DEVICE EXPLANTATION WAS CANCELLED. THERE WAS NO SERIOUS INJURY. THERE WERE NO DEVICE MALFUNCTIONS REPORTED. THEREFORE, THERE WAS NO REPORTABLE EVENT. IF MORE INFORMATION IS RECEIVED THAT SUGGESTS A SERIOUS INJURY, A FOLLOW UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-33, LOT# V821945, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POSSIBLE PROBLEM WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) AND IT WAS SCHEDULED TO BE REMOVED. IT WAS UNKNOWN WHY THE INS WAS GOING TO BE REMOVED. IT WAS STATED THAT THE EXTENSION WAS GOING TO BE CUT AND A BOOT WAS GOING TO BE PLACED ON THE END. THE LEAD AND PART OF THE EXTENSION WERE GOING TO BE LEFT IN THE PATIENT. FOUR DAYS LATER IT WAS REPORTED THAT THE "CASE" WAS ACTUALLY CANCELLED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REMOVAL OF THE DEVICE WAS CANCELLED ON (B)(6) 2013. THE EXPLANT WAS NOT RESCHEDULED. THE DETAILS OF WHY THE DEVICE WAS GOING TO BE REMOVED WERE NOT KNOWN. FURTHER INFORMATION WAS REQUESTED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160977 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 Required Intervention