BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4232154 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21074
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3587A, LOT# L97277, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-09, LOT# L77425, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4) , PRODUCT TYPE: RECHARGER. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 74001, LOT# N231660, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WOULD HAVE THE STIMULATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) ON FOR 1 OR 2 DAYS BEFORE THEY HAD TO TURN IT OFF BECAUSE THE INS SITE GOT IRRITABLE AND ¿BURN¿ WHICH STARTED A COUPLE OF MONTHS AGO. THE PATIENT STATED THAT THEY WERE OAKY WITH DOING THAT FOR A WHILE BUT THEN ON SUNDAY IT BURNED SO BAD AS IF THEY ¿HAD A HOT CURLING IRON UP TO HER HEAD¿. IT WAS NOTED THAT EVEN WITH THE STIMULATION IS TURNED OFF IT WAS STILL ¿VERY IRRITATED. THEY ALSO STATED THAT THE ENTIRE SITE COULD NOT BE TOUCHED ON THE LEFT SIDE OF THEIR HEAD WHERE THE INS WAS. THE PATIENT DID NOT THINK THE LEADS HAD COME OUT BECAUSE THEY HAD ¿SOME SCANS¿ AND THEY KNOW ¿IT¿S THERE¿. IT WAS STATED BY THE PATIENT THAT THEY LOVED THE DEVICE AND HAD BEEN WORKING VERY WELL UP TO THIS POINT BUT NOW THEY COULD NOT STAND IT. NO FURTHER DETAILS, INTERVENTIONS, OR AN OUTCOME WERE REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713848 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR