BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2801035 · Received October 23, 2012

    Report

    Report Number
    3004209178-2012-09433
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    September 25, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377760, LOT# V016985, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 355029, LOT# N080418, IMPLANTED: (B)(6) 2007, PRODUCT TYPE ACCESSORY; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD COUPLING AND/OR COMMUNICATION ISSUES WITH THE DEVICE. THE PATIENT ATTEMPTED TO USE ANTENNA LOCATE TO IMPROVE COMMUNICATION BUT IT WAS UNSUCCESSFUL. IT WAS STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ANGLED AFTER A SEIZURE AND CONSEQUENT FALL THAT OCCURRED 2-3 MONTHS PRIOR TO REPORT. THE PATIENT NOTICED THE INS WAS ANGLED RATHER THAN FLAT THREE DAYS AFTER THE SEIZURE. AN INS FLIP WAS NOT CONFIRMED AT THE TIME. IT WAS ALSO REPORTED THAT THE PATIENT HAD A SEIZURE 3-4 MONTHS PRIOR, AND HAD NOT FELT STIMULATION OR BEEN ABLE TO CHARGE THE DEVICE SINCE THAT TIME. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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