BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 4748588 · Received May 5, 2015

    Report

    Report Number
    3004209178-2015-08452
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Date of Event
    December 25, 2014
    Report Date
    April 15, 2015
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3550-39, LOT# N191758, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NORMALLY FELT A ¿BUZZ¿ IN HER LEG, BUT SHE STOPPED FEELING IT (B)(6) 2014. THE PATIENT BROKE HER LEFT FOOT AT THE BEGINNING OF (B)(6) AND SHE WANTED TO USE HER DEVICE, BUT COULD NOT. DURING THE TIME OF REPORT, THE PATIENT WAS ABLE TO CONNECT WITH HER IMPLANT AND SHE WAS ABLE TO FEEL STIMULATION. STIMULATION WAS FELT MORE ON HER RIGHT SIDE, AND NORMALLY STIMULATION WAS STRONGER ON HER LEFT SIDE. AFTER THE PATIENT TURNED UP HER STIMULATION IN PROGRAM 2, SHE WAS ABLE TO FEEL STRONGER STIMULATION IN HER LEFT FOOT. IT WAS THOUGHT THAT THE PATIENT COULD NOT FEEL STIMULATION/ADJUST BECAUSE THE THERAPY WAS OFF, UNTIL SHE WAS INSTRUCTED ON HOW TO TURN IT ON AGAIN ON THE DAY OF THE REPORT. IT WAS FURTHER REPORTED THAT THE ISSUE WAS RESOLVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295457 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR