BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3764421 · Received April 22, 2014

    Report

    Report Number
    3004209178-2014-07640
    Event Type
    Injury
    Date Received
    April 22, 2014
    Report Date
    March 31, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 399960, LOT# V020191, IMPLANTED: 2002 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: 2002 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2002 , EXPLANTED: 2008 (B)(6); PRODUCT TYPE RECHARGER PRODUCT ID 74002, LOT# N223243, SERIAL# (B)(4), IMPLANTED: 2002 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: 2003 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: 2003 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: 2002 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION. THE PATIENT¿S STIMULATION WOULD NOT TURN ON. THE ISSUES STARTED ABOUT 3 WEEKS PRIOR TO THE REPORT. THE PATIENT SNEEZED ABOUT 2 WEEKS PRIOR TO THE REPORT DUE TO ALLERGIES AND THEY WERE NOT SURE IF THIS CAUSED ANYTHING WITH THE DEVICE NOT WORKING. IT WAS NOTED THAT THE PATIENT¿S REMOTE HAD NOT BEEN WORKING FOR THE 2 WEEKS PRIOR TO THE REPORT. THE REMOTE WAS FULLY CHARGED BUT IT WAS NOT WORKING. THE PATIENT WAS GETTING POOR COMMUNICATION SCREENS WITH THEIR PROGRAMMER AND THEIR RECHARGER. THE PATIENT USUALLY CHARGED TWICE PER WEEK BUT TRIED TO RECHARGE LAST WEEK AND COULD NOT. THE PATIENT NOTED THAT THE RECHARGER SHOWED THAT IT WAS FULLY CHARGED. AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. THE PATIENT TRIED USING THEIR PROGRAMMER WITH AND WITHOUT THE ANTENNA AND GOT A POOR COMMUNICATION SCREEN. THE STIMULATION STOPPED ON ITS OWN. THE PATIENT HAD NOT HAD ANY FALLS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS NO LONGER USING STIMULATION AND THEY WERE PLANNING EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242332 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