BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3833452 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09639
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    May 6, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD PAIN AT THE POCKET SITE. IT WAS STATED THAT HE HAD ¿MASSIVE SWELLING¿ ON THE ENTIRE LEFT FLANK. IT WAS STATED FROM THE BACK TO HIS BUTTOCKS IT WAS SWOLLEN, ¿ALMOST THE SIZE OF A WATERMELON¿. IT WAS STATED THAT THIS WAS THE SECOND TIME THIS HAPPENED THIS MONTH. IT WAS NOTED THAT IT TOOK 3 WEEKS THE FIRST TIME AND THEN IT WENT AWAY, BUT NOW IT WAS BACK. IT WAS REPORTED THAT IT WAS PAINFUL TO TOUCH BUT THAT IT DIDN¿T APPEAR RED. IT WAS STATED THAT THE PATIENT HAS HAD FALLS IN THE PAST, BUT NOT RECENTLY. IT WAS NOTED THAT THE PATIENT COULD NOT REMEMBER WHEN THE FALLS OCCURRED. IT WAS STATED THAT THE PATIENT CURRENTLY HAD THE STIMULATION TURNED OFF ¿BECAUSE IT FELT A LITTLE BETTER WHEN IT WAS OFF¿. IT WAS NOTED THAT THE PATIENT REQUESTED PHYSICIAN LISTINGS BECAUSE HE HAD A FALLING OUT WITH HIS MANAGING HEALTHCARE PROFESSIONAL (HCP) AND CAN¿T GO BACK TO SEE HIM. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED THE LIST OF HCPS AND STATED THAT ONE OF THE HCPS WAS THE ONE HE CURRENTLY SAW. IT WAS STATED THAT THE PATIENT WOULD CALL THE HCP. IT WAS STATED THAT THE FIRST TIME THE PATIENT HAD THE SWELLING ISSUE THE HCP TOLD HIM IT WAS NOT ABSCESSED AND TO LEAVE IT ALONE. IT WAS STATED THAT THIS TIME THE PROBLEM WAS ¿BACK NOW ONLY WORSE AND MUCH MORE PAINFUL¿. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NEW SWELLING AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. IT WAS FURTHER REPORTED THAT THE PATIENT COMPLAINED OF NEW BACK PAIN AND A ¿PINCHED NERVE¿ NEAR THE BACK INCISION. IT WAS STATED THAT THE NEW PAIN WAS PRESENT WITH STIMULATION ON OR OFF. IT WAS STATED THAT THE PATIENT HAD DISCUSSED EXPLANT WITH THE HEALTHCARE PROFESSIONAL (HCP). IT WAS NOTED THE HCP WANTED TO TRY REPROGRAMMING FIRST BEFORE EXPLANT. IT WAS STATED THAT THE PATIENT STATUS WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HIS DEVICE OR THERAPY BUT WAS WORKING WITH HIS HEALTHCARE PROFESSIONAL (HCP)/MANUFACTURER¿S REPRESENTATIVE. IT WAS REPORTED THAT ON (B)(6) 2014 THE MANUFACTURER¿S REPRESENTATIVE DID NOT SHOW UP OR CALL FOR THE APPOINTMENT. THE PATIENT EXPRESSED DISSATISFACTION WITH THE MANUFACTURER¿S REPRESENTATIVE SERVICE. IT WAS STATED THAT THE PATIENT WAS HAVING HIS DEVICE REMOVED AND STATED HE DID NOT WANT TO BE CONTACTED FURTHER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD DECIDED TO HAVE HIS SYSTEM EXPLANTED. IT WAS NOTED THAT THERE WAS NOT YET A TENTATIVE EXPLANT DATE. IT WAS STATED THAT DESPITE ACHIEVING APPROPRIATE STIMULATION TO THE CORRECT AREAS, THE PATIENT DID NOT FEEL LIKE THE STIMULATION WAS HELPING HIS PAIN WHATSOEVER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WANTED TO BE SCHEDULED FOR EXPLANT, BUT IT WAS UNKNOWN IF IT HAD OCCURRED YET. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310631 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 00051 YR Required Intervention