BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 7286035 · Received February 21, 2018

    Report

    Report Number
    3004209178-2018-03690
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    February 24, 2006
    Report Date
    February 21, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    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 CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR COMPLEX REG. PAIN SYNDROME TYPE I. INFORMATION WAS REPORTED THAT A CALL WAS RECEIVED FROM A PATIENT AND VERIFIED SHE NO LONGER HAS THEIR INS. THE PATIENT SAID IT WAS REMOVED DUE TO INFECTION. SHE SAID 6 WEEKS AFTER THE IMPLANT OF THE DEVICE SHE EXPERIENCED PAIN AND HER DOCTOR DECIDED TO REMOVE THE DEVICE. IT WAS ESCALATED TO REG TEAM ON (B)(6) 2018 FOR RESEARCH AND UPDATE. NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130246 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention