BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4121671 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17795
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN FEELING PAIN IN THE FRONT OF HIS RIB CAGE FOR 3 WEEKS. IT WAS REPORTEDLY SO INTENSE THAT SOMETIMES THE PATIENT COULDN¿T ¿TAKE IT¿ WHEN BENDING OVER. THE HEALTH CARE PROVIDER (HCP) DID A GALLBLADDER WORK UP, WHICH CAME BACK NEGATIVE. THE HCP WAS TESTING THE PATIENT FOR AN ULCER. THE HCP ALSO TOLD THE PATIENT THERE WAS A ¿POSSIBILITY THAT AIR GOT INTO THE PATIENT¿S ABDOMEN DURING THE IMPLANT SURGERY AND WAS CAUSING THE PATIENT PAIN.¿ THE PATIENT REPORTEDLY FELT PAIN IF STIMULATION WAS ON OR OFF. THE PATIENT WAS TO GET BACK TO THE MANUFACTURER REPRESENTATIVE WITH UPDATES AFTER HIS ENDOSCOPY. NO DIAGNOSTICS HAD BEEN PERFORMED SINCE THE PATIENT¿S REPROGRAMMING ON (B)(6) 2014. LATER, THE PATIENT WAS GETTING THE PAIN IN THE STOMACH BOTTOM RIGHT SIDE RIB CAGE. HE HAD AN ENDOSCOPY AND ULTRASOUND DONE AND THE HCP WAS ABLE TO DETERMINE THE STIMULATION WAS HITTING A NERVE. IT MAY HAVE BEEN STIMULATING THE VAGUS NERVE. IT WAS CAUSING A BUILDUP OF STOMACH ACID WHICH CAUSED THE PAIN. HE HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) FOR L4 AND L5 AND IT WAS GREATLY HELPING WITH THE PAIN. THE PATIENT WOULD LIKE TO TRY REPROGRAMMING TO SEE IT THAT HELPED. LATER, THE PATIENT HAD ABDOMINAL ISSUES THE NIGHT PRIOR TO (B)(6) 2014. THE GASTROENTEROLOGIST DOCTOR HAD THE PATIENT ON POWDER THAT HELPED THE STOMACH. IT WAS SUSPECTED THAT THE DEVICE COULD HAVE CAUSED THE ABDOMINAL ISSUES. THERE WERE NO FALLS OR ACCIDENTS REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT ¿HE¿ WAS LOOKING TO HAVE THE LEAD REPOSITIONED ON (B)(6) BY THE DOCTOR. ADDITIONAL INFORMATION WAS REQUESTED. IF RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION. THIS REVISION WAS TO MOVE THE LEAD DOWN THE LEAD WAS TOO CEPHALAD. THE MANUFACTURER REPRESENTATIVE WANTED TO KNOW HOW TO DISABLE THE SENSOR, MOVE THE LEAD, AND THEN START FRESH AGAIN. IT WAS NOTED THEY MAY REPLACE THE LEAD, THE FUNCTION WAS OKAY, ONLY THE LOCATION. THE PATIENT HAD THE LEAD REMOVED, IT WAS WAY TOO HIGH. THEY TRIED LOWER IT TO LEVEL 8 BUT THE PATIENT STILL COMPLAINED OF FEELING TWINGES OF STIMULATION IN RIBS. SO THEY GIVE HIM TWO DIFFERENT LEADS. THEY WERE ABLE TO PROGRAM TO MEET THE PATIENT'S NEEDS. ONE WAS PROGRAMED SLIGHTLY LOWER THAN THE OTHER AND THAT GAVE THE PATIENT GOOD COVERAGE. THE PATIENT WAS DOING WELL, THE LEADS HAD GOOD IMPEDANCES. ADAPTIVE STIMULATION WAS SET BACK UP FOLLOWING THE REVISION. EVERYTHING WAS NOTED TO BE FINE WITH THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR LEAD REPLACED AND THE NEW LEAD HAD BEEN MOVED TO A LOWER LEVEL IN THE PATIENT'S SPINE. THE FIRST LEAD WAS AT T7 AND THE PATIENT'S LEAD TIP WAS NOW IN THE MIDDLE OF T8. THE PATIENT WAS HAPPY WITH THE COVERAGE AFTER THE REVISION ON (B)(6) 2014 AND DID NOT HAVE ANY ABDOMINAL STIMULATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S PAIN HAD RETURNED ON (B)(6) 2015. THEIR DEVICE WAS HELPING BUT NOT ENOUGH AND THEY HAD TO HAVE IT UP SO HIGH THAT THEY COULD NOT SLEEP. AT ONE POINT THE PATIENT WAS ON A SHORT DRIVE AND THE PAIN GOT SO BAD THEY HAD TO PULL OVER AND TAKE PAIN MEDICATION AND WAIT FOR IT TO SUBSIDE BEFORE CONTINUING TO DRIVE. THE PATIENT HAD BEEN DOWN TO 3 PAIN PILLS PER DAY BUT WAS NOW BACK UP TO TAKING THEM EVERY FOUR HOURS. THE PATIENT WAS SCHEDULED FOR AN X-RAY AND CT SCAN TO DIAGNOSIS WHAT HAD CHANGED. ON (B)(6) 2015 THE MANUFACTURER REPRESENTATIVE SPOKE TO THE PATIENT AND THEY HAD STATED THAT THEY HAD NOT HEARD FROM THE DOCTOR BUT READ THE REPORT FROM THE IMAGING SCANS AND SAW THAT THEY HAVE ANOTHER BULGING DISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601637 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 00040 YR Required Intervention