BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2893583 · Received January 2, 2013

    Report

    Report Number
    3004209178-2013-00063
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 11, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ERROR CODE 578 WAS CONFIRMED WHEN THE DEVICE WAS INTERROGATED WITH THE CLINICIAN PROGRAMMER. ANALYSIS FOUND THAT THE REPORTED FAILURE WAS DUE TO THE DEVICE'S INABILITY TO ESTABLISH THE CORRECT APP ID (APPLICATION IDENTIFICATION) AND APP ON THE DEVICE. IT WAS NOTED THAT A SOFT POWER-ON-REST (POR) OR A HARD POR DID NOT CORRECT THE APP ID DATA. REPROGRAMMING THE APP RESULTED IN THE DEVICE BEING FULLY FUNCTIONAL. THE EXACT ROOT CAUSE OF THE FAILURE WAS NOT FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377745, LOT # J0564198V, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 377745, LOT # J0564198V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION NO EVAL EXPLAIN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. IT WAS ALSO NOTED THE PATIENT WAS SEEING "DEVICE NOT SUPPORTED" MESSAGE ON THEIR PATIENT PROGRAMMER WHEN TRYING TO TURN THEIR IMPLANTABLE NEUROSTIMULATOR (INS) ON. IT WAS NOTED THE PATIENT TURNED THE INS OFF THE PREVIOUS DAY OR A COUPLE DAYS PREVIOUS. THE PATIENT FULLY CHARGED THE INS A COUPLE DAYS AGO. IT WAS ALSO NOTED THE PATIENT GOT A REPLACEMENT PATIENT PROGRAMMER NOT TOO LONG AGO BUT THEY HAD USED IT SINCE THE REPLACEMENT. IT WAS NOTED THERE WAS A "CALL YOUR DOCTOR" ICON WITH AN ERROR CODE WHEN THE PATIENT ATTEMPTED TO TURN ON THE INS WITH THEIR RECHARGER. PATIENT WAS WALKED THROUGH A SHORT PHYSICIAN RECHARGE MODE (PRM). AFTER THE PRM THE PATIENT CONTINUED TO SEE ERROR CODE WHEN TRYING TO TURN INS ON OR START A NORMAL RECHARGE SESSION WITH THE RECHARGER. PATIENT WAS WALKED THROUGH A SECOND SHORT PRM AND THE PATIENT CONTINUED TO SEE THE ERROR CODE. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH THEIR HEALTH CARE PROVIDER. TEN DAYS LATER IT WAS REPORTED THERE WERE TELEMETRY ISSUES. INS WAS UNRESPONSIVE TO TELEMETRY ATTEMPTS BY PHYSICIAN PROGRAMMER, PATIENT PROGRAMMER AND RECHARGER. IT WAS NOTED THE PATIENT HAD STIMULATION 11 DAYS PRIOR. IT WAS NOTED A SHORT PRM DID NOT COMMUNICATE WITH THE INS. THE ERROR SHOWN "WAS A CORRUPT EEPROM AND PRIMARY PROGRAM WAS UNABLE TO COPY MEMORY." THE PATIENT WILL HAVE THE DEVICE REPLACED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT WAS UNABLE TO COMMUNICATE WITH THEIR IMPLANTABLE NEUROSTIMULATOR (INS) VIA THE RECHARGER OR PROGRAMMER. BOTH RECHARGER AND PROGRAMMER GAVE A 578 CODE. THE REPRESENTATIVE WAS UNABLE TO READ THE INS WITH THE CLINICIAN PROGRAMMER. THE SCREEN STATING "THE COMMUNICATION WAS IN PROCESS" NEVER CHANGED AND NO INFORMATION WAS OBTAINED. IT WAS NOTED A BATTERY REPLACEMENT WAS DONE. THERE WAS NO INJURY OR ADVERSE EVENT TO THE PATIENT. DIAGNOSTIC TESTING AND TROUBLESHOOTING WAS ATTEMPTED. SYMPTOMS INCLUDED RETURN OF ORIGINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention