BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3874443 · Received June 16, 2014

    Report

    Report Number
    3004209178-2014-11618
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    May 19, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3998, LOT# V233248, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A SHOCKING OR JOLTING SENSATION. IT WAS STATED THAT ON SATURDAY AT 6 PM AFTER RECHARGING, THE PATIENT GOT 4 ¿SHARP POKING SENSATIONS¿ AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. IT WAS STATED THAT THE PATIENT WAS SURE THE IMPLANT WAS TURNED ON AT THAT POINT. IT WAS REPORTED THAT AT 3 AM ON SUNDAY MORNING, SHE FELT THE PAINFUL JOLT AGAIN. IT WAS NOTED THAT THE PATIENT HAS TURNED HER IMPLANT OFF SINCE. IT WAS STATED THAT ¿SIX MONTHS AGO, MAYBE MORE, THE PATIENT WOULD FEEL STIMULATION THAT WAS TOO STRONG, THUS SHE WOULD REDUCE STIMULATION TO A COMFORTABLE LEVEL. IT WAS STATED THAT AFTER A WHILE THE STIMULATION WOULD NO LONGER BE FELT AND THE PATIENT WOULD HAVE TO INCREASE STIMULATION UP AGAIN, BUT ONLY TO ENCOUNTER THE STIMULATION BEING TOO HIGH AGAIN, AND SHE WOULD HAVE TO TURN THE STIMULATION DOWN. IT WAS STATED THAT IT¿S HAPPENED LIKE THAT FOR ABOUT ONCE A MONTH AND EACH TIME IT LASTED 3-4 DAYS. IT WAS STATED THAT THE IMPLANT WAS CHECKED BY A MANUFACTURER¿S REPRESENTATIVE A MONTH AGO AND EVERYTHING WAS ¿HUNKY DORY¿. IT WAS NOTED THAT THE PATIENT WAS UNSURE OF THE TIMELINE AND STATED SHE ¿MIGHT HAVE INFORMED ANOTHER MANUFACTURER¿S REPRESENTATIVE OF THIS ISSUE 6 MONTHS AGO¿ AND THAT HER STIMULATION ISSUE MIGHT HAVE BEEN MORE THAN 6 MONTHS. IT WAS NOTED THAT THE PATIENT¿S STATUS WAS ¿UNKNOWN¿. IT WAS NOTED THAT THE PATIENT WAS FEELING STIMULATION IN BOTH LEGS AND BACK AS BEFORE. NO ADDITIONAL INFORMATION RECEIVED. IT WAS STATED THAT THE MANUFACTURER¿S REPRESENTATIVE WAS NOT AWARE OF ANY ISSUE UNTIL HE RECEIVED THE EMAIL REQUESTING FOLLOW-UP. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THE HEALTHCARE PROFESSIONAL (HCP) OR MANUFACTURER'S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS NOTED THAT THE APPOINTMENT WAS (B)(6) 2014. NO ADDITIONAL INFORMATION RECEIVED. IT WAS STATED THAT THE MANUFACTURER¿S REPRESENTATIVE WAS AWARE OF THIS PATIENT BUT HAD NO KNOWLEDGE OF THIS SITUATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE SAW THE PATIENT LAST WEEK. IT WAS STATED THAT HE DID NOT HAVE A SPECIFIC DATE. IT WAS STATED THAT THE PATIENT REPORTED SHE HAD THE SYSTEM FOR A WHILE AND HAD VERY STABLE THERAPY FOR A WHILE. IT WAS STATED THAT THE SYSTEM WAS CHECKED AND EVERYTHING WAS ¿FINE EXCEPT ONE CONTACT ¿0¿ WAS HIGH¿, BUT THAT NONE OF THE PATIENT SETTINGS USED THAT CONTACT AND IT WAS ¿NOT A MATTER OF CONCERN¿. IT WAS STATED THAT THE PATIENT WAS UNHAPPY IN GENERAL AND HAD SEVERAL NON-THERAPY RELATED HEALTH ISSUES. IT WAS STATED THAT ¿AT SOME POINT¿ THE PATIENT HAD WORKED WITH ANOTHER MANUFACTURER¿S REPRESENTATIVE AND IT WAS NOTED THAT THE PATIENT HAD NOT BEEN HAPPY WITH THAT REPRESENTATIVE AT ALL, AND THAT THE PATIENT HAD SEEN SEVERAL MANUFACTURER¿S REPRESENTATIVES IN DIFFERENT TERRITORIES. IT WAS NOTED THAT THE HEALTHCARE PROFESSIONAL (HCP) HAD ASKED EVERYBODY NOT TO FURTHER WORK ON THE PATIENT¿S SCS (SPINAL CORD STIMULATION) UNTIL THE PATIENT GOT HER OTHER HEALTH RELATED ISSUES RESOLVED. IT WAS STATED THAT THE PATIENT HAD AN UNRELATED SPINAL SURGERY SCHEDULED WITH POSSIBLY ANOTHER HCP AND THE SCS HCP WANTED THAT TO BE TAKEN CARE OF FIRST. IT WAS FURTHER REPORTED THAT THE PREVIOUSLY MENTIONED OTHER MANUFACTURER¿S REPRESENTATIVE CHECKED HIS CALENDAR/NOTES AND COULD NOT CONFIRM WHEN THE PATIENT MET WITH HIM. IT WAS STATED THAT HE WOULD ¿GO WITH WHAT HE REMEMBERED FROM THE LAST INTERACTION WITH THE PATIENT. IT WAS STATED THAT HE SAW THE PATIENT ¿MAYBE IN EARLY MAY¿ AND AT THAT POINT THE PATIENT SAID THAT SHE REPORTED THE SHOCKING/ INTERMITTENT STIMULATION ISSUE ABOUT A YEAR AGO TO SOME OTHER MANUFACTURER¿S REPRESENTATIVE, AND HE STATED THAT HE TOOK THAT TO MEAN THAT THE ISSUE WAS ALREADY REPORTED A YEAR AGO. IT WAS STATED THAT HE STILL TRIED TO ¿RE-CREATE THE PATIENT¿S COMPLAINT AND JUST COULD NOT¿. IT WAS STATED THAT EVERYTHING AT THAT POINT WITH THE DEVICE AND THERAPY, WAS REALLY GOOD. IT WAS STATED THAT HE HAD NO OTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353227 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 00072 YR