BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2854906 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11081
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 7, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE REPORTER STATED THAT EVER SINCE THE PATIENT GOT THE IMPLANT SHE HAD NOT BEEN ABLE TO SIT WITHOUT HITTING THE IMPLANT AND IT WAS "DRIVING HER NUTS." IT WAS NOTED THAT THE PATIENT HAD NOT FOLLOWED UP WITH ANY DOCTOR REGARDING HER IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT FOR THE NEW PAIN SHE WAS HAVING AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. IT WAS STATED THAT THE PATIENT COULD NOT TURN STIMULATION UP ANY HIGHER THAN 4.5 VOLTS BECAUSE THE STIMULATION "HURT TOO MUCH, BUT IT WASN'T CONTROLLING THE NEW PAIN SHE WAS HAVING." IT WAS NOTED THAT ADJUSTING THE RATE DID NOT HELP EITHER. THE PATIENT REPORTEDLY LANDED ON HER "WHOLE BOTTOM" WHEN SHE FELL DOWN 3 STEPS "ABOUT 3 WEEKS AGO." IT WAS STATED THAT THE AREA WAS "ALL BLACK AND BLUE FOR QUITE SOME TIME." THE PATIENT REPORTEDLY FELL AGAIN AND CREATED A "BIG KNOT ABOUT THE SIZE OF AN EGG." IT WAS STATED THAT SINCE THEN, THE INS SITE WAS "VERY SORE" AND WAS NOT "SITTING FLAT" IN THE POCKET. IT WAS NOTED THAT THE PATIENT COULD FEEL THE SCREWS IN THE INS. THE PATIENT REPORTEDLY HAD X-RAYS TAKEN WHICH SHOWED NO BROKEN BONES OR RODS. IT WAS STATED THAT IT WAS "VERY DIFFICULT" FOR THE PATIENT TO SIT AGAINST A CHAIR OR CHURCH PEW FOR VERY LONG AS WELL AS BENDING OR STANDING FOR LONG PERIODS OF TIME. THE PATIENT'S STATUS WAS REPORTED AS "FAIR." IT WAS NOTED THAT THE PATIENT WAS ONCE PRESCRIBED FLEXERIL WHICH CAUSED HER TO "BLACK OUT" AND SPEND 4 DAYS IN THE HOSPITAL IN (B)(6) 2011. IT WAS FURTHER NOTED THAT "THEY WEANED THE PATIENT OFF" OF THE LORTABS AND MORPHINE WHILE SHE WAS IN THE HOSPITAL. IT WAS LATER REPORTED THAT PATIENT EXPERIENCED PAIN. IT WAS STATED THAT THE PATIENT HAD TO TURN STIMULATION UP "HIGH" TO GET RELIEF FOR HER BACK, BUT SHE ALSO FELT THE "VIBRATION UP TO UNDER HER BREAST." IT WAS FURTHER STATED THAT IT "CUT THE PATIENT'S WIND OFF" DUE TO ASTHMA. THE PATIENT "GENERALLY" RECEIVED "40-50% RELIEF" WHEN THE DEVICE WORKED. IT WAS STATED THAT THE PATIENT EXPERIENCED PAIN "NO MATTER WHAT BODY POSITION SHE WAS IN." IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR OR REPRESENTATIVE. IT WAS NOTED THE DEVICE WAS "CHECKED AND INCREASED."

    Devices

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