BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2831998 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10254
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 16, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3888 LOT# V705748, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3888 LOT# V736705, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL EXPLANT OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM. THE REASON FOR THE EXPLANT WAS UNKNOWN. NO OTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED DEVICE TESTING AND REPROGRAMMING WERE ATTEMPTED ON MULTIPLE OCCASIONS OVER SEVERAL MONTHS. THE DEVICE NEVER HELPED THE PATIENT MUCH. THE SYSTEM FUNCTIONED NORMALLY, GENERATING CONSISTENT PARASTHESIA IN THE PAINFUL AREAS WITHOUT PAIN RELIEF. THERE WERE NO MALFUNCTIONS SEEN OR CAUSE OF ISSUE DETERMINED. THE REASON FOR EXPLANT WAS DUE TO ELECTION OF PATIENT BASED ON LACK OF PAIN CONTROL. THE PATIENT FULLY RECOVERED AFTER EXPLANT. 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 ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention