BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2875276 · Received December 17, 2012

    Report

    Report Number
    3004209178-2012-11892
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Report Date
    November 27, 2012
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH HER DEVICE OR THERAPY AND WAS WORKING WITH THE DOCTOR OR MANUFACTURER REPRESENTATIVE. THE PATIENT HAD APPOINTMENT SCHEDULED FOR (B)(6) 2013. THE PATIENT REPORTEDLY STILL HAD PAIN AND NOW HER LEGS STIFFEN UP AND SHE COULD NOT RUB THEM OUT. IT WAS ALSO STATED THAT IT ¿HURT BADLY AROUND THE BOX.¿ THE PATIENT WAS RECHARGING FOR 3+ HOURS, TWICE A WEEK. THE PATIENT MENTIONED THAT SHE NEEDED HER BOX READJUSTED. IF THE PATIENT TURNED IT UP TO HIGH, IT HURT HER STOMACH. IT WAS ALSO MENTIONED THAT THE PATIENT HAD TWO MORE SURGERIES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED THE EVENT WAS ATTRIBUTED TO THE RECHARGER. NO ABNORMAL IMPEDANCE MEASUREMENTS. NO SURGICAL INTERVENTION OCCURRED. IT WAS NOTED THAT THE DEVICE WOULD NOT BE RETURNED. IT WAS REPORTED THAT THE PATIENT WAS REPROGRAMMED ON 2013 (B)(6) AND IN (B)(6) 2013. A NEW RECHARGING UNIT WAS GIVEN ON 2013 (B)(6). NO PROBLEM HAD BEEN REPORTED SINCE THE CHANGE. SYMPTOMS ASSOCIATED WITH THE EVENT WERE LISTED AS BURNING OF SKIN AT THE SITE OF RECHARGER. THE PATIENT WAS NOT HOSPITALIZED AND NO INJURY OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A WARM FEELING AT THE DEVICE POCKET. THE REPORTER STATED THAT ABOUT SIX MONTHS AFTER IMPLANT, THE PATIENT STARTED EXPERIENCING HEATING/A WARM FEELING AT THE DEVICE IMPLANT SITE. IT WAS REPORTED THAT THE SKIN AROUND THE IMPLANT GOT RED AND ITCHY. IT WAS NOTED THAT AFTER THE IMPLANT THE PATIENT NOTICED A CORNER OF THE DEVICE WAS STICKING OUT, AND CURRENTLY SHE FELT LIKE THE TOP OF THE DEVICE WAS STICKING OUT. IT WAS REPORTED THAT THE IMPLANT SITE WAS VERY SENSITIVE, AND WHEN THE PATIENT SAT IN A CHAIR SHE HAD TO PUT A PILLOW ON HER BACK. IT WAS NOTED THAT THE PATIENT WAS SICK "A WHILE AGO" AND WAS TOLD SHE WAS DEHYDRATED AND HER BODY TEMPERATURE WAS TOO HIGH. THE REPORTER STATED THAT IT WAS HARDER FOR THE PATIENT TO FIND THE IMPLANT WITH HER RECHARGER, AND THE PATIENT FELT THAT THE DEVICE WAS AT AN ANGLE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH HER HEALTH CARE PROVIDER ON (B)(6) 2012. 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 'TOO HOT' ERROR MESSAGE WAS RECEIVED WHILE RECHARGING. IT WAS STATED THAT THE ERROR APPEARS APPROXIMATELY 1.25 HOURS INTO A RECHARGE. IT WAS FURTHER STATED THAT RECHARGING 'BURNS,' SO THE PATIENT WOULD NORMALLYRECHARGE OVER A T-SHIRT OR 'SWEATS' AND LEANED AGAINST A PILLOW. THE "HOT BURNING" WHILE RECHARGING HAD BEEN HAPPENING FOR THE PAST 6 MONTHS. IT WAS NOTED THAT THE PATIENT USUALLY HAD A 'HIGH CORE TEMP.' THE PATIENT WAS INSTRUCTED TO USE A LIGHT T-SHIRT, NOT TO LEAN AGAINST A PILLOW TO ALLOW MORE AIR FLOW, AND TO STOP RECHARGING AFTER 45 MINUTES TO ALLOW THE SYSTEM TO COOL DOWN. THE PATIENT HAD A FOLLOW-UP APPOINTMENT WITH HER MANAGING PHYSICIAN ON B)(6) 2013.

    Description of Event or Problem · 1

    FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED THE CAUSE OF THE EVENT WAS THE IMPLANTABLE NEUROSTIMULATOR (INS) PLACEMENT WAS IN A 'BAD' LOCATION FOR THE PATIENT. IT WAS NOTED THERE WAS POOR SURGICAL PLACEMENT OF THE INS FOR THE PATIENT AND THE INS KEPT CATCHING ON THE PATIENT'S WAISTLINE OF THEIR PANTS. X-RAYS WERE TAKEN AND THE LEAD PLACEMENT WAS OKAY, NO MIGRATION NOTED. THERE WERE NO HIGH IMPEDANCES. SYMPTOMS INCLUDED INCREASED WARMTH AT THE INS SITE. SURGICAL INTERVENTION HAD NOT OCCURRED YET. IT WAS NOTED THERE WAS NO INJURY TO THE PATIENT AND NO HOSPITALIZATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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