BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3269531 · Received August 7, 2013

    Report

    Report Number
    3004209178-2013-12952
    Event Type
    Malfunction
    Date Received
    August 7, 2013
    Report Date
    July 12, 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
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 389133, LOT# J0306963V, IMPLANTED: 2003-02-26 PRODUCT TYPE: LEAD. PRODUCT ID: 389133, LOT# J0306963V, IMPLANTED: 2003-02-26 PRODUCT TYPE: LEAD. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: 2006-12-07 PRODUCT TYPE: EXTENSION. PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT WARMTH AT THE POCKET WITH STIMULATION ON THAT RADIATED UP HER SIDE AND WHILE RECHARGING, AND WOULD GET THE THERMOMETER ON HER RECHARGER, WHICH JUST STARTED OCCURRING. THE PATIENT¿S HUSBAND FELT THE PATIENT¿S SKIN AND INDICATED IT FELT WARM AT THE POCKET. THE WARMTH AT THE POCKET HAD BEEN OCCURRING SINCE THE DEVICE SUTURES CAME LOOSE AND THE DEVICE STARTED MOVING AROUND IN THE POCKET. IT WAS NOT KNOWN IF THE PATIENT HAD WARMTH WITH STIMULATION ON IF SHE TURNED STIMULATION OFF. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN USING STIMULATION FOR A WHILE DUE TO WARMTH WITH USE, HAD BEEN USING IT TODAY, THAT THE WARMTH WAS OCCURRING REGULARLY, BUT NOT CONSTANTLY, AND THAT STIMULATION COVERAGE WAS PERFECT AND WORKED GREAT. THE PATIENT DID NOT WANT TO HAVE HER STIMULATION REPROGRAMMED. IMPEDANCES WERE CHECKED AND FOUND TO BE IN NORMAL RANGE. THE PATIENT HAD BEEN ABLE TO CHARGE HER DEVICE UP TO 100%. IT WAS INDICATED THAT SINCE THE DEVICE STARTED MOVING AROUND IN THE POCKET, THE PATIENT HAD A HARD TIME GETTING COUPLING BARS FILLED, BUT IF HELPED, SHE WAS ABLE TO GET 8 BARS. THE PATIENT HAD NOT HAD ANY FALLS OR BEEN DOING ANY EXTREME ACTIVITIES, AND IT WAS UNKNOWN IF THERE WAS ANY WEIGHT LOSS/GAIN. THE PATIENT WAS GOING TO TRY STIMULATION FOR ANOTHER WEEK AND SEE HOW SHE WAS DOING AT THAT TIME. IT WAS REVIEWED POSSIBLY CHANGING OUT THE DEVICE SOONER IF THE PROBLEM GOT WORSE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S DOCTOR WAS CONSIDERING A DEVICE REPLACEMENT AND POSSIBLE REVISION. THE PATIENT WAS CURRENTLY RECEIVING EFFECTIVE THERAPY. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S HEALTHCARE PROFESSIONAL WAS WAITING TO SEE THE PATIENT IN THEIR OFFICE TO DETERMINE HOW THEY WOULD LIKE TO PROCEED. ADDITIONAL INFORMATION WAS 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 NOT KNOWN. IT WAS NOTED THAT THE EVENT WAS ATTRIBUTED TO THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE PATIENT FELT BURNING AND SHOCKING AT THE POCKET. IT WAS FURTHER NOTED THAT SIGNS AND SYMPTOMS ASSOCIATED WITH THE REPORTED EVENT INCLUDED SHOCKING, BURNING, AND WARMTH AT THE INS POCKET. IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION AS A RESULT OF THE EVENT. IT WAS FURTHER NOTED THAT THE PATIENT OUTCOME WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370301 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1