BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3052324 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-05993
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3487A-33, LOT# J0219962V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 3487A-33, LOT# J0217084V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; 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

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HER DEVICE OR THERAPY. SHE HAD RECEIVED ASSISTANCE FROM HER DOCTOR OR MANUFACTURER REPRESENTATIVE AND HER CONCERNS WERE RESOLVED. NO APPOINTMENT DATES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN FINE UP UNTIL A COUPLE OF WEEKS PRIOR TO THE REPORT. IT WAS STATED THAT THE PATIENT HADN'T USED IT FOR THE PAST COUPLE OF WEEKS. IT WAS STATED SHE HAD CHANGED THE BATTERIES IN HER PATIENT PROGRAMMER. IT WAS STATED SHE HADN'T SEEN HER HEALTHCARE PROFESSIONAL (HCP) FOR HER INS SINCE IT HAD BEEN IMPLANTED BECAUSE SHE HADN'T HAD TO. IT WAS STATED THE PATIENT DID SEE HER HCP EVERY 7-8 WEEKS FOR CHECK UPS NORMALLY, BUT NOT BECAUSE OF THE INS. IT WAS STATED SHE WENT TO TURN IT ON WITH THE PATIENT PROGRAMMER AND THE REGULAR SCREEN CAME UP THEN IT SHUTOFF. NO STIMULATION SENSATION WAS REPORTED. IT WAS STATED IT WAS THE SAME BATTERIES SHE HAD BEEN USING FOR THE LAST 4 YEARS FOR THE PATIENT PROGRAMMER. PATIENT PROGRAMMER AND CONTROL MAGNET WERE THEN USED WITHOUT THE DETACHABLE ANTENNA AND THE PATIENT GOT THE POOR COMMUNICATION SCREEN. IT WAS STATED THAT THE PATIENT HAD AN APPOINTMENT IN TWO DAYS BECAUSE THE INS WASN'T WORKING AND THAT THE PATIENT THOUGHT THE INTERNAL UNIT NEEDED TO BE REPLACED. IT WAS STATED THAT THE PATIENT KNEW HER INS WAS ONLY GOING TO LAST 4 YEARS AND HADN'T HAD ANY ISSUES WITH IT OR THE PATIENT PROGRAMMER SINCE IT HAD BEEN PUT IN. 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

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT WAS NOT CURRENTLY USING THEIR STIMULATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156993 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR