BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3299016 · Received August 20, 2013

    Report

    Report Number
    3004209178-2013-14891
    Event Type
    Malfunction
    Date Received
    August 20, 2013
    Date of Event
    March 30, 2013
    Report Date
    July 26, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 377760, LOT# V004735, IMPLANTED: 2006-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 377760, LOT# V003346, IMPLANTED: 2006-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION AND THAT HE NEVER HAD THERAPEUTIC EFFECT. IT WAS STATED THAT THE STIMULATION WAS GOING ON AND OFF FOR 4 MONTHS AND AT THE TIME OF THE REPORT HE WAS NOT FEELING THE STIMULATION AT ALL. IT WAS REPORTED THAT 4 MONTHS PRIOR TO THE REPORT THE PATIENT WAS TOLD THE INS WOULD BE DEPLETED BY THE (B)(6) OF 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A DECREASE IN EFFECTIVENESS OF STIMULATION. IT WAS NOTED THIS WAS AN ONGOING EVENT. IT WAS NOTED THE PATIENT NEEDED TO CONTINUALLY INCREASE THE AMPLITUDE OF STIMULATION IN ORDER TO GET THE SAME RESULTS. THE DEVICE WAS INTERROGATED AND NOTED AS WORKING PROPERLY. THE EVENT WAS NOTED AS POSSIBLY RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. INTERVENTION INCLUDED REPROGRAMMING IN AUGUST 2013. THE PATIENT WAS NOT ABLE TO INCREASE THE STIMULATION HIGHER THAN 3.0V. HE WAS NOT ABLE TO ADJUST THE STIMULATION AND IT WAS FOUND THAT THE UPPER LIMIT WAS REACHED. UPPER LIMIT WAS REACHED AT 3.0V ON PROGRAMS 1 ,2 AND 3. HE WAS REPROGRAMMED ON 08/16/2013 BECAUSE PROGRAM 2 QUIT WORKING A COUPLE WEEKS AGO. HE WAS NOW ON GROUP B. HE DOES NOT GET ANY RELIEF AT 3.0V, THE DEVICE WAS USUALLY INTO 4-5V. THE COMPANY REPRESENTATIVE CONFIRMED THAT THEY MET WITH THE PATIENT. HIS LIMITS WERE SET AND THE DEVICE WAS REPROGRAMMED. HE WAS HAPPY IN THE END WITH EVERYTHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401642 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR