BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3772324 · Received April 25, 2014

    Report

    Report Number
    3004209178-2014-08093
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT JUST HAD HIS UNIT PUT IN ABOUT A MONTH PRIOR TO REPORT. IT WAS REPORTED HE NEEDED IT READJUSTED TO GET IT BACK WORKING BECAUSE IT WAS NOT DOING ANYTHING TO HIS BACK AT ALL. IT WAS LOGGED HE HAD AN APPOINTMENT ON THE TUESDAY FOLLOWING REPORT AT 10AM. IT WAS REPORTED WHEN THE PATIENT WAS ASKED WHEN IT STARTED NOT WORKING THAT IT HAD JUST STARTED NOT WORKING AND THE PATIENT'S BACK HAD BEEN KILLING HIM FOR THE PREVIOUS 3 DAYS. IT WAS LOGGED THAT THE PATIENT WAS TOLD HE WOULD HAVE TO GO BACK IN AND GET IT READJUSTED. IT WAS NOTED HE WAS DOING GOOD ON HIS LEGS BUT RIGHT AT THE BELT LINE WAS WHERE HE WAS HURTING. IT WAS REPORTED IT WORKED PRETTY GOOD WHEN IT WAS FIRST PUT IN.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THERE WAS A LOSS OF STIMULATION THAT HAS GRADUALLY GOTTEN WORSE OVER THE LAST SIX MONTHS. THE PATIENT WAS HAVING PROBLEMS WITH HIS KNEES. HIS BACK WAS OK. THE CHANGE IN THERAPY/SYMPTOMS WAS CONSIDERED TO BE GRADUAL. THE INDICATIONS FOR USE WERE NON-MALIGNANT PAIN AND CHRONIC LOW BACK PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252532 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR