BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5885840 · Received August 18, 2016

    Report

    Report Number
    3004209178-2016-17116
    Event Type
    Malfunction
    Date Received
    August 18, 2016
    Date of Event
    January 1, 2016
    Report Date
    October 3, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS: PRODUCT ID: 3998, LOT# V113343, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 399930, LOT# V182611, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW DETERMINED THAT CODES NO LONGER APPLY TO THIS EVENT. 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 WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR OTHER CHRONIC/INTRACT PAIN (TRUNK/LIMBS). IT WAS REPORTED THAT THE PATIENT COULD TURN AND MANIPULATE THE INS IN THE POCKET. SHE ALSO STATED THAT SHE FELT THE LEAD CONNECTION RIGHT AT THE SURFACE AND THE PLACEMENT OF THE INS WAS AWKWARD BECAUSE IT WAS RIGHT AT THE WAIST LINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED OVERTIME THEY WERE ABLE TO FEEL THE BATTERY AND LEADS CLOSE TO THE SURFACE OF THEIR SKIN. AT THE CURRENT TIME NOTHING HAD BEEN DONE REGARDING THE DEVICES BEING VERY CLOSE TO THE SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539495 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 50 YR