BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3846296 · Received June 3, 2014

    Report

    Report Number
    3004209178-2014-10081
    Event Type
    Injury
    Date Received
    June 3, 2014
    Report Date
    May 14, 2014
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3550-29, LOT# N201197, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OVER-DISCHARGE (OD) WAS SUSPECTED. THE PATIENT WAS NOT ABLE TO COMMUNICATE WITH THE STIMULATOR. THE PATIENT WAS ALSO UNABLE TO GET COUPLING BOXES. THE LAST RECHARGE WAS OVER A YEAR AGO. IT WAS FURTHER REPORTED THAT THE PATIENT TRIED AGAIN TO CHARGE 5 DAYS LATER AND WAS UNABLE TO ESTABLISH COMMUNICATION WITH THE PROGRAMMER. THE REPOSITION ANTENNA SCREEN WAS DISPLAYED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD STOPPED USING THE SYSTEM AS SHE DIDN¿T THINK IT WAS WORKING. IT WAS FURTHER REPORTED THAT THE PATIENT WAS GOING TO THE PAIN PHYSICIAN¿S OFFICE ON (B)(6) 2014 TO DO A PHYSICIAN MODE RESET. IF ADDITIONAL INFORMATION WAS REQUESTED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT OPTED TO HAVE THE STIMULATOR REMOVED INSTEAD OF MOVING FORWARD WITH A PHYSICIAN MODE RESET. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323853 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention