BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3790372 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08516
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    August 1, 2016
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR ((B)(4)) FOUND INSIGNIFICANT ANOMALIES AND WAS FUNCTIONALLY OKAY. IT WAS NOTED THAT THE DEVICE PASSED ALL FUNCTIONAL TESTING AND A CONNECTOR BLOCK LEAKAGE TEST. THERE WAS NO INFORMATION IN THE FILE TO INDICATE THAT THE COMPLAINT OF A ¿BURNING SENSATION¿ IS HEAT RELATED; THEREFORE, NO ADDITIONAL TESTING WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR ((B)(4)) FOUND THERE WERE INSIGNIFICANT ANOMALIES AND WAS FUNCTIONALLY OKAY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE BURNING AND JOLTING SENSATION STARTED ALMOST IMMEDIATELY AFTER IMPLANT. THE PATIENT STATED THAT AT FIRST THE JOLTING WAS NOT THAT BAD BUT AFTER SHE HAD PNEUMONIA (WHICH INVOLVED A LOT OF COUGHING), THE JOLTING STARTED GETTING PRETTY INTENSE. THE PATIENT NOTED THAT THE JOLTING WOULD THROW HER HIPS OUT EVEN WHEN THE STIMULATION WAS OFF. IT WAS NOTED THAT THE PATIENT WAS AFRAID TO TURN THE STIMULATION ON. SINCE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED, THE PATIENT HAD NOT FELT ANY BURNING OR JOLTING. IT WAS NOTED THAT ONLY THE BATTERY WAS REMOVED AND NOT THE LEADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S THERAPY NEVER REALLY WORKED SINCE IMPLANTATION. THE PATIENT HAD A HARD TIME GETTING STIMULATION TO WHERE ALL THE PAIN WAS AND IT WAS REPORTED THAT THE PATIENT NEEDED REPROGRAMMING. IT WAS REPORTED THE STIMULATION WAS IN THE PATIENT¿S LEGS AND IT WAS SUPPOSED TO BE IN THEIR BACK. IT WAS REPORTED THAT THE THERAPY HAD BEEN BOTHERING THE PATIENT FOR THE PAST COUPLE WEEKS AND THAT THE PREVIOUS SUNDAY THE IMPLANTABLE NEUROSTIMULATOR (INS) GOT CAUGHT ON THE LIP / STUCK ON THE BACK OF A CHAIR WHEN SHE WAS STANDING UP AND THE INS AREA HAD BEEN BURNING AND TENDER SINCE (B)(6). IT WAS NOTED THAT THE PATIENT WAS NOT ABLE TO SEE ANYTHING ON THE INS AREA. IT WAS REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS REPORTED THAT THE STIMULATOR ¿HAD NOT REALLY WORKED REALLY GOOD¿ SINCE BEING IMPLANTED. IT WAS NOTED THAT THEY HAD BEEN TRYING TO WORK ON IT. IT WAS LATER REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY, AND HAD JUST HAD AN APPOINTMENT ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE SOMETIMES BURNED THE PATIENT AT THE POCKET. THE REPORTER NOTED THAT IMPEDANCES WERE NORMAL AND MULTIPLE REPROGRAMMINGS WERE DONE. IT WAS ALSO NOTED THERE WERE X-RAYS DONE. PATIENT SYMPTOMS INCLUDED BURNING SENSATION AND LESS THAN 50% THERAPY RELIEF AT THE DEVICE POCKET AND RIGHT SIDE IMPLANT. IT WAS REPORTED THERE WAS A COMPLETE EXPLANT ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT CONFIRMED THAT THE INS ALWAYS HAD STUCK OUT AND WHEN THEY SAT IN A CHAIR IT WOULD GET STUCK. IT WAS NOTED THAT THERE WAS A BURNING SENSATION AT THE INS SITE AND WOULD "JOLT" THEM. THE PATIENT JUST COULD NOT STAND IT ANYMORE AND HAD THE INS REMOVED IN (B)(6) 2014. THE LEADS WERE STILL IMPLANTED. THE PATIENT WAS WORKING WITH THEIR DOCTOR ABOUT GETTING ANOTHER DEVICE PUT IN. THE INDICATIONS FOR USE FOR THE IMPLANTED DEVICE WERE NOTED AS DEGENERATIVE DISC DISEASE AND SPINAL PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED ON (B)(6) 2014 DUE TO PERIODIC SHOCK ING AND CONSTANT BURNING PAIN TO THE PATIENT THAT STARTED AFTER IMPLANT. IT WAS UNKNOWN WHICH EXPLANT DATE WAS CORRECT. THE REPORTER NOTED THAT THE DEVICE WOULD STILL SHOCK THE PATIENT EVEN WHEN IT WAS OFF. IT WAS NOTED THAT SINCE THE INS WAS EXPLANTED THE PATIENT WAS NO LONGER FEELING THE SHOCKING/BURNING SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267081 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 00046 YR Required Intervention