BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2822667 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-09999
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 8, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL# (B)(4),IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT WENT TO THE DOCTOR THIS YEAR TO HAVE HIS DEVICE CHECKED OUT, THEY TOLD HIM ONE OF THE LEADS WAS NOT GIVING OUT ENOUGH POWER BUT TO KEEP USING IT ANYWAY. IT WAS ALSO REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT TRIED USING HIS PROGRAMMER LAST WEEK AND IT WOULD NOT WORK AND LAST CHARGED HIS DEVICE APPROXIMATELY TWO WEEKS AGO. THE PATIENT REPOSITIONED PROGRAMMER OR ANTENNA OVER THE DEVICE AND WAS ABLE TO ADVANCE TO THE STATUS SCREEN OF THE PROGRAMMER AND CONFIRM HIS PROGRAMMER BATTERIES HAD FULL LONGEVITY AND HIS DEVICE WAS A QUARTER CHARGED. IT WAS RECOMMENDED THAT THE PATIENT RECHARGE HIS DEVICE. 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

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT HAD INCREASED PAIN AND WAS NOT GETTING ENOUGH STIMULATION TO PAINFUL AREAS. THE REPORTER STATED THAT THE PATIENT NEEDED ADJUSTING OF SIMULATION SETTINGS. THE PATIENT'S DEICE WAS REPROGRAMMED TO SATISFACTION IN (B)(6) 2012. THERE WAS NO HOSPITALIZATION OR PATIENT INJURY ASSOCIATED WITH THIS EVENT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1