BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3243703 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12203
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 3, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN A CAR ACCIDENT ON (B)(6). IT WAS ALSO REPORTED THAT THE PATIENT HAD FIBROMYALGIA AND HER EARS PLUGGED AND THEN UNPLUGGED. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOLLOWING THE CAR ACCIDENT, BUT CANCELLED IT BECAUSE SHE DIDN¿T FEEL SAFE DRIVING. THE PATIENT PLANNED TO HAVE ONE OF HER CHILDREN TAKE HER TO URGENT CARE / ER. IT WAS REPORTED THAT STIMULATION WASN¿T DOING A LOT TO HELP THE PATIENT. THE PATIENT MET WITH A MANUFACTURER REPRESENTATIVE A MONTH AGO WHO DID FIX THE ¿JIGGLING SENSATION¿ IN HER STOMACH. IT WAS NOTED THAT A TECH BEFORE THAT DID AN ADJUSTMENT AND THAT WAS WHEN SHE HAD THE STOMACH JIGGLING AND HATED IT BECAUSE SHE HAD GASTROESOPHAGEAL REFLUX DISEASE. WHILE THE STOMACH JIGGLING WAS GONE, STIMULATION STILL WASN¿T WORKING. THE HEALTHCARE PROVIDER STATED THAT IT WOULD TAKE A WHILE TO GET SYMPTOM RELIEF, AND THE PATIENT FOUND THAT FRUSTRATING BECAUSE IT WORKED SO WELL DURING THE TRIAL. THE PATIENT STATED THAT THERE WAS A CONCERN ABOUT SCAR TISSUE BUILDUP. WHILE REPORTING THESE ISSUES, IT WAS NOTED THAT THE PATIENT¿S HEARING WAS PLUGGING UP AGAIN. IT WAS LATER REPORTED THE CAUSE OF THE EVENT WAS A CAR ACCIDENT AND PADDLE MIGRATION. IT WAS ALSO STATED THERE WAS A REVISION OF THE PADDLE AFTER IT MOVED. IT WAS NOTED THE HEALTHCARE PROVIDER CHECKED HOSPITALIZATION BUT THE PATIENT'S OUTCOME WAS REPORTED AS NO INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS NOT GETTING RELIEF LIKE SHE SHOULD AND WAS NOT EVEN GETTING 50% RELIEF WITH HER STIMULATOR. IT WAS ALSO REPORTED THE PATIENT WAS UPSET BECAUSE SHE WAS NOT PROGRAMMED FOR DIFFERENT BODY POSITIONS AND SHE WANTED TO BE; SHE WAS GOING TO FOLLOW UP WITH HER PHYSICIAN FOR PROGRAMMING. IT WAS NOTE THE PATIENT HAD CONSIDERED HAVING HER DEVICE TAKEN OUT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED AN X-RAY WAS DONE TO MAKE SURE THEY WERE PLACING THE PERMANENT LEAD WIRE IN THE SAME SPOT AS THE TRIAL LEAD AND THEN THEY "TOOK A SLIVER OF THE PATIENT'S BACK BONE OUT TO PLACE A PADDLE" SO THAT THE LEAD WOULD STAY IN THE CORRECT SPOT. IT WAS STATED THE PATIENT'S PERMANENT IMPLANT WAS NOT WORKING AS GOOD AS THEIR TRIAL AND THEY HAD NOT FOUND THE RIGHT ADJUSTMENT. IT WAS REPORTED THE PATIENT'S DEVICE WAS "NOT WORKING THAT GREAT." IT WAS STATED THE PATIENT HAD PAIN IN THEIR KNEE, FIBROMYALGIA, A HERNIATED DISK AND OSTEOARTHRITIS AND THE DEVICE COULDN'T TREAT PAIN FOR ALL OF THOSE DIAGNOSES BUT THE PATIENT STATED THEIR DOCTOR THOUGHT IT COULD TREAT ALL HEALTH ISSUES. IT WAS NOTED EVERY ADJUSTMENT SEEMED TO MAKE THE PAIN COVERAGE A LITTLE BETTER BUT IT WAS NOT GREAT. THE PATIENT STATED THEIR STIMULATION TREATS SOME OF THEIR PAIN BUT THEY STILL NEEDED MEDICATION TO TREAT PAIN ALSO. IT WAS NOTED THE PATIENT SOMETIMES "COULD NOT STAND ANYMORE", WOULD BE IN "SCREAMING BACK PAIN" FROM STANDING SO MUCH AND WALKED AROUND HUNCHED OVER BECAUSE THEY DIDN'T HAVE THE STRENGTH TO STAND UP STRAIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343397 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention