BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4181794 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19921
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    October 13, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; 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; PRODUCT ID NEU_UNKNOWN, SERIAL # UNKNOWN, PRODUCT TYPE UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    THE COMPANY REPRESENTATIVE CONFIRMED A COUPLE MONTHS LATER THAT THEY HAVE CALLED THE PATIENT BUT HAS NOT HEARD BACK FROM THEM.

    Description of Event or Problem · 1

    A COUPLE WEEKS LATER IT WAS REPORTED THAT THE PATIENT WAS STILL HAVING DIFFICULTIES. THE PATIENT WAS USING THE ANTENNA LOCATOR AND WAS CLICKING THE X AND THEN THE GREEN BUTTON TOO QUICKLY, THIS WAS CAUSING THE ISSUES. THE PATIENT WAS INSTRUCTED TO DO THE PROCESS SLOWER. HOWEVER, THE PATIENT EXPLAINED THAT SHE WAS DOING THAT BUT WAS STILL HAVING THE ISSUES. THE PP THE PATIENT RECEIVED FROM THE DEVICE MANUFACTURER DID NOT WORK AND WAS SHIPPED BACK. THE PATIENT WAS NOT SURE IF HER THERAPY WAS ON OR OFF AND WAS NOT SURE WHAT SHE DID. THE RECHARGER WAS NOT CHARGING AND NOT WORKING. THE CONNECTOR PIN CORD WAS EXPOSED. THE PATIENT ALSO SHIPPED BACK THE ENTIRE RECHARGING SYSTEM. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014. IT WAS LATER REPORTED ON THE DAY OF THE PATIENT¿S APPOINTMENT THAT THE ¿IN THE BOX¿ SCREEN ON THE PP DISPLAYED AND WAS LIKELY FROM THE ANTENNA LOCATE FEATURE THE PATIENT USED LAST NIGHT BECAUSE SHE WAS HAVING TROUBLE GETTING A CONNECTION. THE 8840 (CLINICIAN PROGRAMMER) WAS USED TO INTERROGATE AND THAT CLEARED THE ¿IN THE BOX¿ SCREEN WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE PATIENT PROGRAMMER. THE PATIENT WAS NOT ABLE TO MAKE ADJUSTMENTS WITH OR WITHOUT THE ANTENNA ATTACHED. THE PATIENT PROGRAMMER WAS NOT CONNECTING TO IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE PAST 2-3 WEEKS. THE PROGRAMMER WILL NOT INTERROGATE. ANOMALY APPEARS TO HAVE OCCURRED THROUGH PRODUCT USE. IT WAS REPORTED THAT THE PATIENT IS HAVING SOME INCREASED PAIN DUE TO A BIG DROP IN TEMPERATURE. THE PATIENT DOES NOT ADJUST OFTEN WITH THE PATIENT PROGRAMMER AND THE LAST TIME SHE ATTEMPTED TO ADJUST WAS APPROXIMATELY 2-3 WEEKS AGO. THE PATIENT ADJUSTS MORE IN THE WINTER WITH THE WEATHER BECAUSE IT SEEMS TO BOTHER HER MORE. IN THE SUMMER THE PATIENT DOES NOT HAVE AS MANY ISSUES SO SHE DOES NOT HAVE TO USE THE PATIENT PROGRAMMER AS OFTEN. THE SYMPTOMS WERE REPORTED TO BE GRADUAL AND NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT WAS REPORTED. IT WAS CONFIRMED THAT THE PATIENT WAS ABLE TO TURN THE STIMULATION ON OR OFF WITH THE RECHARGER. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION WITH THE PATIENT PROGRAMMER (PP) AND THE DISPLAYED SHOWED THE ¿IN THE BOX¿ ICON. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED A NEW PP FROM REPAIRS A FEW WEEKS BACK AND SHE WAS STILL HAVING THE SAME PROBLEM WITH POOR COMMUNICATION SO SHE ASSUMED THE PROBLEM WAS WITH THE ANTENNA AND NOT THE PP. THE PATIENT REQUESTED AN ANTENNA. THE ANOMALY APPEARED TO HAVE OCCURRED THROUGH PRODUCT USE. NO PATIENT INJURY REPORTED. A REQUEST WAS MADE TO HAVE THE MANUFACTURER'S REPRESENTATIVE (REP) CONTACT THE PATIENT. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662190 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 00045 YR