BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3843254 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09956
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    April 10, 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

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3778-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3778-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, 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 THE PATIENT HAD A COMMUNICATION PROBLEM IMPLANTABLE NEUROSTIMULATOR (INS) AND A OVERDISCHARGE CONDITION WAS SUSPECTED. IT WAS NOTED THAT THE PATIENT HAD A FALL 9 MONTHS AGO AND INJURED THEIR RIGHT SHOULDER. THE PATIENT WAS TO HAVE SURGERY ON (B)(6) 2013. THE PATIENT STATED THAT THEY HAD THE STIMULATION FOR THEIR OTHER SHOULDER, WHICH HAD NOT BEEN BOTHERING HER, SO SHE WAS NOT USING HER INS DEVICE AND HAD NOT RECHARGED IN TWO MONTHS. THE USE OF THE ANTENNA LOCATE FEATURE ON THE RECHARGER UNIT RESULTED IN A POWER-ON-RESET (POR) MESSAGE TO BE DISPLAYED ON THE RECHARGER WHICH THEN LEAD TO THE NORMAL RECHARGING SCREEN. IT WAS LATER REPORTED (ON THE SAME DATE) THAT THE PATIENT FELT AN OVERSTIMULATION SENSATION AND WAS NOT ABLE TO TURN THE STIMULATION OFF. IT WAS NOTED THAT THE PATIENT DID NOT HAVE THEIR PROGRAMMER BUT DID HAVE THEIR RECHARGER WITH THEM. IT WAS REPORTED THAT THE HISTORY OF EXACTLY WHAT HAPPENED WAS UNCLEAR. THE PATIENT MET WITH THE MANUFACTURER¿S REPRESENTATIVE IN THE HOSPITAL WHERE IT WAS OBSERVED THAT THE PATIENT WAS ¿JOLTING¿ AND ¿TWITCHING SIGNIFICANTLY¿ AND WAS QUITE DISTRESSED. IT WAS NOTED THAT THE PATIENT HAD A CERVICAL PLACEMENT. INTERROGATION OF THE INS SHOWED AN ERROR CODE OF ¿0X8¿ ON THEIR CLINICIAN PROGRAMMER. A PHYSICIAN MODE RECHARGE (PMR) PROCEDURE WAS CONDUCTED TO CLEAR THE POR AND THE DEVICE ISSUE WAS RESOLVED. THE PATIENT WAS GOING TO CALL WHEN SHE WAS READY TO GO TO THE CLINIC TO BE PROGRAMMED AND GET CHARGED UP. FOLLOW UP INFORMATION RECEIVED 3 DAYS LATER CLARIFIED THAT THE PATIENT¿S SHOULDER ISSUE HAD NOTHING TO DO WITH THEIR INS DEVICE. IT WAS ALSO REPORTED THAT THE PATIENT HAD RECENTLY MOVED AND WAS NOT ABLE TO FIND HER REMOTE. WHEN THE PATIENT ATTEMPTED THE ANTENNA LOCATE FEATURE SHE ENDED UP WITH ¿SOME DEFAULT¿ THAT EXPANDED HER PULSE WIDTH AND THEREFORE STRENGTH. IT WAS NOTED THAT THE PATIENT WAS ¿VISIBLY VIOLENTLY TWITCHING¿ IN THE EMERGENCY ROOM. THE PATIENT WAS REPROGRAMMED BY THE MANUFACTURER¿S REPRESENTATIVE WHICH IMMEDIATELY RESOLVED THE ISSUES. SHE WAS DISCHARGED WITH NO SEQUELAE. THE PATIENT WAS GOING TO SEE THEIR PAIN DOCTOR (AND MANUFACTURER¿S REPRESENTATIVE) WHEN THEY HAD SUFFICIENTLY RECOVERED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321366 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 00051 YR