BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 6095942 · Received November 11, 2016

    Report

    Report Number
    3004209178-2016-23771
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    June 1, 2015
    Report Date
    November 11, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994610430
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    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 FAMILY MEMBER AND CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN OFF FOR ABOUT A YEAR NOW, SINCE AROUND (B)(6) 2015. THE PATIENT HAD A BILIARY BYPASS SURGERY FOR THEIR STOMACH WHICH THEY THOUGHT WAS IN (B)(6) 2015 AND WHEN THEY WENT TO TURN THE INS BACK ON AFTER SURGERY THE STIMULATION WAS EXTREMELY, TOO HIGH SO THE PATIENT TURNED THE INS BACK OFF. SOMEWHERE IN THEIR TRAVELS THE PATIENT LOST THE EQUIPMENT THAT WENT WITH THE INS. IT WAS CONFIRMED THAT THE PATIENT HAD LOST THE CONTROLLER FOR THE IMPLANT. IT WAS CONFIRMED THAT THE STOMACH SURGERY WAS UNRELATED TO THE DEVICE OR THERAPY. THERE WAS RECENT ELECTROMAGNETIC INTERFERENCE (EMI). ADDITIONAL INFORMATION WAS RECEIVED FROM A FAMILY MEMBER ON (B)(6) 2016 REPORTING THAT THE PATIENT WAS IN PAIN BUT THE PATIENT PROGRAMMER WAS STOLEN IN THE HOSPITAL WHILE THEY WERE HAVING STOMACH SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746165 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR