BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4049087 · Received August 29, 2014

    Report

    Report Number
    3004209178-2014-16167
    Event Type
    Injury
    Date Received
    August 29, 2014
    Report Date
    August 6, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37791, SERIAL # UNKNOWN, PRODUCT TYPE RECHARGER; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39286-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 39286-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(6), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A WARM SENSATION IN OR AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET DURING RECHARGING. THE PATIENT STATED THAT THE INITIAL IMPLANT AREA GOT WARM DURING RECHARGING. THE PATIENT CONFIRMED THAT SINCE THIS LAST REVISION THAT THIS REMAINED THE CASE. IT WAS STATED THAT IT WAS 'BOILING HOT' AND THE PATIENT ¿MADE PEOPLE TOUCH IT TO CONFIRM THE HEAT.¿ IT WAS NOTED THAT THE MANUFACTURER¿S REPRESENTATIVE RAN ELECTRODE IMPEDANCES AND PROVIDED JUST A FEW RANGES THAT ALL LOOKED VERY GOOD (0 = 1353 ¿ 1630; 3= 1306 ¿ 1535; 13= 1087 ¿ 1459). IT WAS NOTED THAT A POST-OP X-RAY LOOKED ¿LIKE THE LEAD WAS SLIGHTLY SLANTED TO THE LEFT A BIT.¿ THE PATIENT NOTED THAT SHE WENT TO HOSPITAL 2 WEEKS AGO BECAUSE OF THE HEATING DURING THE RECHARGING PROCESS BECAUSE SHE THOUGHT SHE MAY HAVE AN INFECTION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) WAS DAMAGED. IT WAS NOTED THAT THE PATIENT ALSO NEEDED 2 SPACERS. IT WAS NOTED THAT NO DEVICE WAS RETURNED, C500. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S SKIN AT THAT BATTERY SITE GOT RED AND IRRITATED WHEN SHE WAS CHARGING. IT WAS NOTED THAT THE PATIENT DID REPLACE THE ANTENNA AND WAS USING THE SPACER. IT WAS REPORTED THAT THE PATIENT CONTINUED TO FEEL UNCOMFORTABLE STIMULATION IN HER ENTIRE RIB AREA WHEN THE STIMULATOR WAS ON.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NOT FOLLOWED UP WITH SCHEDULED APPOINTMENTS. IT WAS STATED THAT WHEN THE MANUFACTURER¿S REPRESENTATIVE SAW THE PATIENT IN THE HEALTHCARE PROFESSIONAL (HCP) OFFICE AN IMPEDANCE CHECK WAS RUN AND THINGS WERE OKAY. IT WAS NOTED THAT THE HCP HAD WANTED TO REPLACE THE ENTIRE SYSTEM WITH PERCUTANEOUS LEADS BUT THE PATIENT HAS NOT RETURNED TO THE OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529753 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 00039 YR Hospitalization| O