BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2543176 · Received April 20, 2012

    Report

    Report Number
    3004209178-2012-02536
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Report Date
    April 10, 2017
    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
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL: 377645, LOT#: V003613, IMPLANTED: 2006 (B)(6), EXPLANTED: NA, LEAD MODEL: 377645, LOT#: V003613, IMPLANTED: 2006 (B)(6), EXPLANTED: NA, EXTENSION MODEL: 3708120, SERIAL#: (B)(4), IMPLANTED: 2006 (B)(6), EXPLANTED: NA, EXTENSION MODEL: 3708120, SERIAL#: (B)(4), IMPLANTED: 2006 (B)(6), EXPLANTED: NA, PROGRAMMER MODEL: 37742, SERIAL#: (B)(4), CONCOMITANT SYSTEM: INS MODEL: 7427, SERIAL#: (B)(4), IMPLANTED: 2002 (B)(6), EXPLANTED: NA, LEAD MODEL: 3887-33, LOT#: J0125363V, IMPLANTED: 2002 (B)(6), EXPLANTED: NA, EXTENSION MODEL: 7495LZ51, SERIAL#: (B)(4), IMPLANTED: 2002 (B)(6), EXPLANTED: NA, PLUG/BOOT MODEL: 3550-09, LOT#: LA2114, IMPLANTED: 2002 (B)(6), EXPLANTED: NA, PROGRAMMER MODEL: 7435, SERIAL#: (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED CODING; PREVIOUSLY REPORTED CODES ARE NO LONGER APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN HIS HIP AND AT THE LEAD LOCATIONS (NEAR THE SPINE). THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) 'FAILED' SEVERAL YEARS AGO, BUT NO ACTIONS WERE TAKEN TO REMEDY THE SITUATION. THE PATIENT WANTED THE DEVICE REMOVED. IT WAS NOTED THAT THE PATIENT HAD A PREVIOUS INS THAT ALSO 'FAILED' APPROXIMATELY 1 YEAR BEFORE THE DEVICE IN QUESTION WAS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) HAS NOT WORKED IN YEARS, AND THEY WANT IT REMOVED. THEY ALSO NOTED THAT IT IS PAINFUL WHERE THE WIRES ARE ON THEIR SPINE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT WAS IMPLANTED FOR MULTIPLE BACK OPERATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR