BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3071067 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06655
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 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
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3587A25, LOT# N104366, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3587A25, LOT# N104366, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3887-33, LOT# J0546574V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WIRE CAME DOWN AND WAS PUSHING AGAINST THE PATIENT'S SKULL BEHIND THE LEFT SIDE OF THE SKULL NEAR THE EAR. THE REPORTER STATED THAT THE PATIENT COULD ALSO SEE THE WIRE PUSHING AGAINST THE SPINE. IT WAS REPORTED THAT THE LEAD JERKED AROUND AND CAUSED THE PATIENT TO FEEL NUMBNESS IN THE CHEEK AT NIGHT. THE REPORTER STATED THAT THE PATIENT HAD TO SIT WITH A PILLOW TO AVOID PUSHING AGAINST THE CHAIR OR SOFA. IT WAS REPORTED THAT THE ISSUE HAD BEEN PRESENT FOR A YEAR TO A YEAR AND A HALF. THE REPORTER STATED THAT THE PATIENT WAS GOING TO SEE HER HEALTHCARE PROVIDER FOR A CT SCAN AND AN X-RAY OF HER SPINE THE WEEK OF THE REPORT. IT WAS REPORTED THAT THE DEVICE SYSTEM STOPPED WORKING EVERY TWO TO THREE MONTHS AFTER IT HAD BEEN REPROGRAMMED, AND THIS HAD BEEN GOING ON FOR TWO YEARS. IT WAS NOTED THAT THE PATIENT WANTED TO BE REPROGRAMMED. IT WAS INDICATED THAT THE PATIENT'S HEALTHCARE PROVIDER MAY HAVE DETERMINED THAT THE DEVICE NEEDED TO BE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN AND THE EVENT WAS ATTRIBUTED TO THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE PATIENT WAS GOING TO SPEAK WITH A SURGEON. IMAGING WAS DONE ON (B)(6) 2013 AND THERE WERE NO ABNORMALITIES. IT WAS REPORTED THAT THE PATIENT FELT THAT THE LEAD HAD MOVED DOWN, THERE WAS NO THERAPEUTIC EFFECT, AND THERE WAS FACIAL NUMBNESS. IT WAS NOTED THAT THE PATIENT DIDN¿T REQUIRE HOSPITALIZATION AND THERE WAS NO INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS NOTED THAT BOTH THE PATIENT AND THE DOCTOR WANTED THE SYSTEM REMOVED. IT WAS NOTED THAT THE PATIENT GOT DEPRESSED THAT THEIR DEVICE WAS HAVING PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172494 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