BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2854067 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11046
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 5, 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, 377875 LOT# V013122, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-75 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REVISION THAT WAS PREVIOUSLY REPORTED OCCURRED IN (B)(6) 2012. THE IMPLANTABLE NEUR OSTIMULATOR (INS) WAS REPOSITIONED IN THE PATIENT'S RIGHT HIP AREA BECAUSE THE INS WAS 'TURNED.' THIS WAS CAUSING THE POOR RECHARGING. SINCE THEN, IT WAS STATED THAT PATIENT HAS NOT HAD ANY ISSUES WITH RECHARGING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE COUPLING AND/OR COMMUNICATION ISSUES. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS "SLIGHTLY TILTED" AND A "BIT DEEP" FOR OPTIMAL RECHARGING. SPACERS HAD BEEN TRIED IN THE PAST, BUT WERE NOT EFFECTIVE. IT WAS REPORTED THAT THE INS WAS CHARGING MORE THAN EXPECTED. IT WAS ALSO INDICATED THAT THE PATIENT HAD A SITUATION WHERE THEY WERE UNABLE TO RECHARGE. ELECTRODE IMPEDANCES WERE BETWEEN 442-612 OHMS. THERAPY IMPEDANCES WERE REPORTED AS NORMAL. A LITTLE MORE THAN FOUR MONTHS LATER, IT WAS REPORTED THAT DIAGNOSTICS SHOWED THE BATTERY TO BE "TOPPING OFF" EACH TIME IT RECHARGED. A POCKET REVISION WAS DONE TO MAKE IT "MORE SHALLOW." THE DATE OF THE PROCEDURE WAS UNKNOWN. IT WAS STATED THAT THE PATIENT WAS CHARGING "EASILY, WITHOUT DIFFICULTY" SINCE THE REVISION. NO FURTHER INFORMATION WAS REPORTED AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    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