BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2821061 · Received November 6, 2012

    Report

    Report Number
    3004209178-2012-09950
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 8, 2012
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 39286-65 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING COUPLING AND/OR COMMUNICATION ISSUES. THE PATIENT HAD A REVISION ABOUT A WEEK AGO AND C HANGED THE POCKET, MOVED UP A LITTLE BIT AS THE BATTERY HAD DROPPED. NOW THE PATIENT WAS HAVING TROUBLE GETTING COUPLING AND ONLY GOT 2 BARS. ADDITIONAL INFORMATION RECEIVED REPORTED A SUSPECTED DEVICE FLIP, ALTHOUGH IT WAS NOT CONFIRMED AT THE TIME. SUBSEQUENT INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HAVING A REVISION ON HER DEVICE POCKET ON OCTOBER 18. FURTHER INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD INCREASED PAIN RELATED TO NO STIMULATION WORKING DUE TO DEAD DEVICE. THE REVISION LAST WEEK INCLUDED REPLACING THE DEVICE AND REVISION OF THE POCKET. THE PATIENT WAS GETTING GREAT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Required Intervention