BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 5792116 · Received July 13, 2016

    Report

    Report Number
    3004209178-2016-14161
    Event Type
    Injury
    Date Received
    July 13, 2016
    Report Date
    July 13, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 377745, LOT# V010634, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 377745, LOT# V009143, IMPLANTED: (B)(6) 2008, 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 CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR HEAD/NECK (NON-MALIGNANT). IT WAS REPORTED A PAIN DOCTOR PULLED ON COMPONENTS DURING A REPROGRAMMING SESSION AND THE PATIENT HAD TO HAVE A REVISION. THE PATIENT NOTED THAT ONE WIRE WAS PULLED UP AND THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD MIGRATED DOWN. A REVISION HAD OCCURRED AND IT WAS NOTED THAT THE PATIENT RECOVERED COMPLETELY. NO PATIENT SYMPTOMS WERE REPORTED REGARDING THIS EVENT. IT WAS NOTED THAT THIS HAD OCCURRED 2-3 YEARS AFTER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444991 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