BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3011832 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03949
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 21, 2020
    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
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# V003187, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    DUE TO IMDRF HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES NO LONGER APPLY TO THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION SEVERAL WEEKS PRIOR TO THIS REPORT. IT WAS NOTED THAT TWO YEARS PRIOR TO THIS REPORT, ONE ROW OF THEIR 8 ELECTRODES STOPPED WORKING. IT WAS STATED THAT IMPEDANCES WERE TESTED AND IMPEDANCES WERE >3,000 OHMS. IT WAS NOTED THAT THE PATIENT'S ENTIRE SYSTEM WAS REPLACED WITH A NEW SYSTEM. IT WAS ALSO NOTED THAT AFTER CHECKING THE ORIGINAL SYSTEM, IT WAS DETERMINED THAT THE LEAD WAS THE ISSUE. IT WAS STATED THAT THE PATIENT'S OUTCOME WAS ALIVE WITH NO INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON FEBRUARY 5, 2020. IT WAS REPORTED THAT THEIR INS STOPPED PREMATURELY; THERE AS A LOSS OF THERAPEUTIC EFFECT. THEY REPORTED IT STOPPED NO LATER THAN (B)(6) 2013, AND IT WAS REPLACED ON (B)(6) 2013. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113445 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention