BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2931653 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01049
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 9, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL #(B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A BLISTER OR BURN AT THE END OF A RECHARGE SESSION THAT WAS ABOUT AN HOUR LONG. IT WAS NOTED THAT THIS RECHARGE SESSION WAS A LONGER SESSION THAN NORMAL. THE PATIENT FELT A "WARM SENSATION" AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET WHEN RECHARGING. IT WAS NOTED THE PATIENT'S INS WAS LOCATED IN THE LEFT FLANK AREA AND THEY WERE CHARGING "AS THEY USUALLY DO." IT WAS STATED THE PATIENT DID NOT NOTICE A TEMPERATURE WARNING SCREEN BEING DISPLAYED AT ANY TIME. THE RECHARGE ANTENNA FELT HOT WHEN THE PATIENT REMOVED IT FROM THEIR SKIN AND IT WAS AT THAT TIME THE SORE WAS NOTICED. THE SORE WAS NEAR THE INCISION. TWO DAYS LATER, IT WAS REPORTED THAT NO MALFUNCTIONS WERE SEEN AND NO INTERVENTIONS WERE PLANNED. IT WAS STATED THAT THE PATIENT HAD A NEW RECHARGER AND THE WOUND WAS HEALING. A FOLLOW REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION ON THE BURN DURING RECHARGING INDICATED THAT ON (B)(6) 2013 THE PATIENT WAS USING THE RECHARGER FOR ABOUT AN HOUR WHEN IT FELT LIKE SOMETHING WAS WRONG. THE PATIENT TOOK THE BELT OFF AND NOTICED BLOOD RUNNING DOWN HIS LEFT LEG. WHEN THE BLOOD WAS CLEANED OFF, THERE WAS A HOLE ABOUT THE SIZE OF A PENCIL AND ABOUT A 1/8 DEEP. IT WAS STATED THAT "NO THERMOMETER ON THE SCREEN" WAS SEEN. ONE WEEK LATER IT WAS STATED THAT THE DATE FOR THE INCIDENT DESCRIBED ABOVE WAS (B)(6) 2013. ON THAT DATE, THE PATIENT WAS CHARGING HIS IMPLANTABLE NEUROSTIMULATOR (INS) WITH ANTENNA AND WHEN HE STOPPED HE HAD A BURN WHERE THE ANTENNA WAS. IT WAS STATED THAT "TOO HOT WARNING SCREEN" DID NOT APPEAR. AFTER THE PATIENT WAS GIVEN A NEW RECHARGER, THE INCIDENT DID NOT OCCUR AGAIN. ONE DAY LATER IT WAS INDICATED THAT THE PATIENT WAS STILL USING THE INS AND RECHARGING.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT'S BURN HAD HEALED AND THAT THEY HAD CONTINUED WITH THEIR THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ANTENNA FELT TOO HOT TO HOLD. THE RECHARGER WAS RETURNED TO THE MANUFACTURER. ANALYSIS OF THE RECHARGER FOUND NO ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37054 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 00078 YR