BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2842358 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10641
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 26, 2012
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD, PRODUCT ID: 37744, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL ON THE DEVICE SIX MONTHS PRIOR TO THE REPORT AND EXPERIENCED A CHANGE IN STIMULATION LOCATION. THE PATIENT STATED SHE SAW A MANUFACTURER REPRESENTATIVE FOUR WEEKS PRIOR TO THE REPORT "WHO SAID THAT THE WIRES HAD MOVED". HOWEVER, ON THE (B)(6) PRIOR TO THE REPORT THE PATIENT SAW HER HEALTHCARE PROVIDER'S (HCP) ASSISTANT WHO TOOK X-RAYS AND NOTED THAT THE LEADS WERE "IN THE CORRECT PLACE". THE PATIENT TURNED OFF STIMULATION, BUT EXPERIENCED A "BURNING, STINGING, AND PAINFUL SENSATION" IN HER BACK AND BUTT, IN ADDITION TO THE PAIN DUE TO THE DEVICE BEING OFF. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012 REPORTED THAT THE PATIENT EXPERIENCED PAIN IN HER RIB CAGE WHEN STIMULATION WAS ON. THE PATIENT STATED THAT IF SHE TURNED OFF STIMULATION THE PAIN IN HER RIB CAGE STOPPED, BUT THEN SHE STARTED TO HAVE "PAIN ALL OVER HER BODY". THE PATIENT ALSO STATED THAT STIMULATION WAS NOT HITTING HER LOWER BACK LIKE IT SHOULD. THE PATIENT HAD ACUTE PAIN AND SHE HAD EXPERIENCED IT FOR A "COUPLE MONTHS". THE PATIENT STATED THAT THIS WAS NOT RELATED TO THE FALL MENTIONED EARLIER. THE PATIENT SAW A HCP ABOUT "3-4" WEEKS PRIOR TO THIS REPORT AND THE X-RAYS WERE NOT "CLEAR". THIS LED THE PATIENT TO SEE ANOTHER HCP WHO TOOK X-RAYS ON (B)(6) 2012, WHICH SHOWED NO ISSUES WITH THE DEVICE. THIS HCP SUGGESTED THE DEVICE BE REPROGRAMMED OR EXPLANTED. THE PATIENT TRIED USING DIFFERENT GROUPS WITH HER PROGRAMMER, BUT HAD BEEN "UNSUCCESSFUL" WITH GETTING RELIEF FROM THERAPY. ON (B)(6) 2012 THE MANUFACTURER REPRESENTATIVE STATED THAT THEY HAD NOT BEEN IN CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1