BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 5786974 · Received July 12, 2016

    Report

    Report Number
    3004209178-2016-14036
    Event Type
    Injury
    Date Received
    July 12, 2016
    Report Date
    July 12, 2016
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3587A25, LOT# N171817, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3587A25, LOT# N266246, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING THE PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT PAIN AND POST TRAUMATIC NEURALGIA. IT WAS REPORTED THAT THE PATIENT'S UNIT WAS UNABLE TO BE CHARGED. IT WAS ALSO REPORTED THAT THE PATIENT HAD THREE REPROGRAMMING SESSIONS AND HIS PERIPHERAL NERVE STIMULATOR WAS UNABLE TO COVER HIS DORSAL FOOT PAIN. THE PATIENT FELT TINGLING IN THE VENTRAL AND LATERAL PORTIONS OF THE FOOT. THE PATIENT HAD NOT CHARGED FOR THE SIX MONTHS PRIOR TO (B)(6) 2016 BECAUSE HE HAD NOT USED IT FOR A YEAR. THE REP DID NOT ATTEMPT A POWER ON RESET (POR) RESET BECAUSE THE PATIENT WAS HAVING THE UNIT EXPLANTED. THE PATIENT WAS TO UNDERGO A SPINAL CORD STIMULATION TRIAL TO SEE IF THIS WOULD COVER HIS PAIN. THE SURGICAL INTERVENTION WAS PLANNED BUT HAD NOT BEEN SCHEDULED. IT WAS NOTED THAT THE ISSUE OCCURRED DURING NORMAL USE AND THE PATIENT WAS ALIVE WITH NO INJURY. THE PAIN ISSUE HAD NOT BEEN RESOLVED AND NEITHER THE EXPLANT NOR THE TRIAL HAD BEEN SCHEDULED AS OF (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440031 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