BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2864101 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11352
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 14, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 39565-30 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37742 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, IN 2007, THE PATIENT EXPERIENCED DIFFICULTY WALKING FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS). SPECIFICALLY, THE PATIENT HAD TO WALK WITH A CANE TO PREVENT THEMSELVES FROM FALLING AND NOTED THAT THEIR LEG "WOULD COME OUT FROM UNDERNEATH" THEM. THE PATIENT'S PHYSICAL THERAPIST TOLD THEM THAT THE FALLS CAUSED THEM TO HAVE "KNEE TROUBLE". THE PATIENT BELIEVED THAT THE STIMULATION WAS TOO HIGH. THE PATIENT HAD THEIR STIMULATION ON FOR 2 HOURS THEN OFF FOR 2 HOURS PER INSTRUCTIONS FROM THE MANUFACTURER'S REPRESENTATIVE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD A BURNING SENSATION FOLLOWING A FALL AND PAIN IN HIS KNEES. THE PATIENT REPORTED A BURNING SENSATION IN LOWER LUMBAR WHEN STIMULATION WAS ON, AND STIMULATION CAUSES HIS LEGS TO GIVE OUT ON HIM, RESULTING IN FALLS; THE PATIENT NOTED HE HAD BURNING SENSATION BEFORE HIS FALLS. THE PATIENT REPORTED CONTINUING TO HAVE MIGRAINES, BLURRED VISION, AND BURNING SENSATION IN HIS LOWER BACK. THE PATIENT INDICATED HE WAS PROGRAMMED A COUPLE OF YEARS AGO THAT CAUSED HIM HACKING AND GAGGING AND HIS PHYSICIAN DIDN'T ADDRESS ISSUE. THE PATIENT STATED "IN HIS OPINION" HIS PAST PHYSICIANS HAVE NEVER DONE ANY SORT OF TESTING ON THE DEVICE OR THE LEADS. THE PATIENT INDICATED THAT HIS PRIMARY PHYSICIAN GAVE HIM ORAL MEDICATION TO HELP MANAGE SYMPTOMS AND AT THIS POINT THE PATIENT WOULD LIKE THE DEVICE EXPLANTED. THE PATIENT NOTED THAT HE HAD TRIED ALL THE PROGRAMS ON THE PROGRAMMER BUT STILL CONTINUED TO HAVE TROUBLE WITH THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 Required Intervention