BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3040902 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04857
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 14, 2013
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HAVING COUPLING AND COMMUNICATION ISSUES. THE PATIENT WAS ABLE TO ACHIEVE 2-6 COUPLING BARS (OUT OF A MAXIMUM OF 8) WHEN RECHARGING, AND THE PATIENT HAD BEEN ATTEMPTING TO CHARGE FOR 2-3 DAYS WITHOUT GETTING TO A FULL CHARGE. THE RECHARGING DIFFICULTY HAD OCCURRED SINCE IMPLANT. ANTENNA LOCATE WAS USED DURING TROUBLESHOOTING, BUT NO INDICATION OF BETTER COUPLING WAS REPORTED. IT WAS NOTED THE PATIENT HAD SEEN THE "ANTENNA TOO HOT" SCREEN BEFORE, AND IT WAS REPORTED THE PATIENT WOULD CHARGE BY LYING ON THE ANTENNA. IT WAS REPORTED THE PATIENT ALSO HAD STIMULATION IN THE WRONG LOCATION, AND THAT THE DEVICE COULD NOT BE "CALIBRATED" CORRECTLY. THE PATIENT HAD COVERAGE "EVERYWHERE BESIDES HER BACK (WHERE SHE NEEDED IT)". STIMULATION WAS REPORTED TO HAVE BEEN IN THE BOTTOM OF FEET, STOMACH, RIB CAGE, BUT NOT THE BACK. THE DEVICE HAD BEEN REPROGRAMMED 5 TIMES. IT WAS REPORTED THE "IMPLANT TURNS OFF" WHEN THE PATIENT WOULD MOVE. IT WAS NOTED DURING ONE OF THE REPROGRAMMING SESSIONS SETTINGS WERE AT 1.2 V AND WERE INCREASED UP TO 9.4 V AND THE PATIENT NOTICED NO DIFFERENCE. X-RAYS WERE REPORTED TO HAVE SHOWN THAT THE LEADS WERE IN THE RIGHT PLACE. THE PATIENT HAD A SCHEDULED APPOINTMENT ON (B)(6) 2013, WHERE ADAPTIVE STIMULATION WAS GOING TO BE IMPLEMENTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT DID NOT HAVE ANY CONCERNS WITH THE DEVICE THERAPY BUT DID REPORT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) DID NOT WORK AND WAS REMOVED ON (B)(6) 2013. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142760 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention