BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3241090 · Received July 22, 2013

    Report

    Report Number
    3007566237-2013-02425
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3877-45, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-29, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REVEALED THAT PATIENT CODE (B)(4) DOES APPLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS AT THE CLINIC WITH THE MANUFACTURER REPRESENTATIVE TO GET STIMULATION OUT OF HER RIGHT LEG. THE PATIENT HAD THE DEVICE IMPLANTED FOR RIGHT-SIDED POST-THORACOTOMY PAIN WITH GOOD COVERAGE OF AREA AND PAIN RELIEF. IT WAS NOTED THAT AROUND THE TIME THE PATIENT HAD A LIDOCAINE INFUSION ABOUT FOUR MONTHS AGO, THE DEVICE POCKET SEEMED SORE. THE PATIENT'S DOCTOR THOUGHT THE POCKET MIGHT BE THIN AFTER SHINING LIGHT IN AREA, BUT DID NOT SEEM TO SEE ANY POCKET EROSION AND THE MANUFACTURER REPRESENTATIVE DID NOT SEE ANY VISIBLE TODAY. IT WAS NOTED THAT THE PATIENT'S DEVICE MOVED WITH POSITIONAL CHANGE AND THE PATIENT HAD SENSITIVITY AROUND IT, BUT DID NOT FEEL IT HAD ANYTHING TO DO WITH HER FEELING STIMULATION IN HER RIGHT LEG. IT WAS INDICATED THAT THE PATIENT'S PAIN DOCTOR WAS UNABLE TO GET RID OF THE LEG STIMULATION VIA REPROGRAMMING AND THAT THE LEG STIMULATION WENT AWAY WHEN THE DEVICE WAS SHUT OFF. THE PATIENT HAD "BACK ISSUES," BUT DID NOT THINK THEY WERE CAUSING RIGHT LEG STIMULATION. THE PATIENT HAD HAD CT AND X-RAYS, AND COULD SOMETIMES FEEL STIMULATION IN HER LEFT LEG, BUT FELT IT GREATER IN THE RIGHT. IT WAS NOTED THAT THE RIGHT LEG STIMULATION WAS POSITIONAL, WAS WORSE IN SUPINE AND DESCENDING STAIRS, AND CONTRIBUTED TO THE PATIENT FALLING ON STAIRS, WHEREIN SHE NOW DESCENDS WITH GOOD LEG FIRST. THE PATIENT INDICATED THAT SHE USED TO DRIVE WITH STIMULATION AND THAT SHE WAS IN A MINOR ACCIDENT THAT SHE THOUGHT WAS CAUSED BY STIMULATION IN THE RIGHT LEG NOT ALLOWING HER TO FEEL THE BRAKE DUE TO "NUMBNESS." THE PATIENT INDICATED THAT SHE NO LONGER DRIVES WITH STIMULATION ON. ALL IMPEDANCES TESTED NORMAL, TRIED VARIOUS ELECTRODE COMBINATIONS AND RE-TESTED EXISTING PROGRAMS, BUT THE REPRESENTATIVE WAS UNABLE TO COME UP WITH ANY PROGRAMS THAT SUCCESSFULLY COVERED THE PATIENT'S PAIN AREA THAT EXCLUDED HER RIGHT LEG STIMULATION. WHEN THE THORAX AREA WAS COVERED, THE PATIENT HAD TO TURN STIMULATION UP TO FEEL IT IN THE THORAX, AT WHICH POINT IT WAS FELT IN THE RIGHT LEG. DESPITE THE LEG STIMULATION, THE PATIENT HAD GOOD THORAX STIMULATION COVERAGE AND THE PATIENT'S MEDICATIONS HAVE REMAINED STABLE. THE PATIENT USED STIMULATION ALL THE TIME, EXCEPT WHEN DRIVING NOW. THE DEVICE MEASURED 3.965 V. IT WAS NOTED THAT THE REPRESENTATIVE CALLED THE PHYSICIAN TO DISCUSS IF THE PHYSICIAN THOUGHT THE LEAD MAY HAVE MOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S PHYSICIAN AND NURSE DECIDED THEY WOULD LIKE TO REPLACE THE PATIENT'S DEVICE WITH A RESTORE SENSOR DUE TO PATIENT'S POSITIONAL SENSITIVITY. IT WAS NOTED THE LEADS WOULD STAY IN PLACE BECAUSE THEY ADEQUATELY COVERED PATIENT'S PAIN. IT WAS REPORTED DATES FOR THE REPLACEMENT WERE DISCUSSED BUT NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341445 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37702

    Patients

    Seq Age Sex Outcome Treatment
    1