BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4103019 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17416
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    March 1, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, 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; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD ISSUES WITH HER SYSTEM STARTING (B)(6) 2013. THE PATIENT HAD BEEN HAVING DIFFICULTY WITH HER THERAPY AND ALSO HAD DIFFICULTY GETTING HER CURRENT PROGRAMS TO WORK FOR HER. HER THERAPY WAS NOT WORKING AS EXPECTED. THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEADS WERE BROKEN. THE INS WAS NOT CHARGING WHICH STARTED IN FEBRUARY. THE PATIENT WOULD LEAVE IT ON FOR HOURS AND NOTICED IT HAD DIED LAST NIGHT. THE PATIENT NORMALLY KEPT THE INS CHARGED, EVEN THOUGH THE LEAD WAS BROKEN. NORMALLY THE INS WENT FROM A FULL BATTERY TO ½ BATTERY WITHIN 2 WEEKS, BUT LAST NIGHT IT WAS EMPTY. THE PATIENT SUCCESSFULLY CHARGED 2 WEEKS AGO AND IT WAS FINE LAST WEEK. AT THE BEGINNING OF THE YEAR, THE INS TOOK LONGER TO CHARGE. IT NEVER TOOK MORE THAN 2 HOURS TO FULLY CHARGE. WHEN THE PATIENT TRIED TO GET IT TO CHARGE IT WOULD NOT GO MORE THAN ½. THE PATIENT WOULD HAVE IT ON AT NIGHT AND IT WOULD CUT OFF. THE PATIENT¿S RECHARGER (INSR) WAS OVERHEATING IN THE BEGINNING OF THE YEAR. THE PATIENT WOULD WEAR IT AT WORK AND IT WOULD ¿JUST OVERHEAT¿ WHEN SHE WOULD BE SITTING DOWN. THE PATIENT WENT TO THE PHYSICIAN REGARDING THE PROBLEMS RECHARGING, AND THAT IS WHEN THEY TOLD HER THE LEAD WAS BROKEN. THE REP TOLD THE PATIENT AT A REPROGRAMMING APPOINTMENT IN MARCH THAT THE LEAD WAS BROKEN. THE REP COULD NOT REPROGRAM THE PATIENT BECAUSE THE LEAD WAS BROKE. THE PATIENT THOUGHT SHE BROKE THE LEAD WHEN SHE LIFTED SOMETHING HEAVY IN THE END OF 2011-2012. THE PATIENT ENDED UP GETTING A MUSCLE SPASM AND PAIN AROUND THE INS AND THAT WAS THE ONLY THING SHE COULD THINK OF TO EXPLAIN WHY THE LEAD BROKE. IN 2013, SHE HAD SHARP SPURTS OF PAIN OR PAIN AT THE IMPLANT SITE. THE PATIENT WAS UNSURE WHAT WAS GOING ON WITH IT. THE PATIENT STARTED EXPERIENCING MORE PAIN 2-3 WEEKS AGO FROM HER COMPLEX REGIONAL PAIN SYNDROME (INFORMATION OMITTED REGARDING CRPS AND ONSET OF PAIN) AND NEEDED HER DEVICE. THE PATIENT NOTED SHE DID NOT USE HER STIMULATION THERAPY ALL THE TIME AND THAT SHE NEEDED THE THERAPY THE MOST DURING THE WINTER MONTHS. THUS, THE PATIENT STARTED PLANNING ON GETTING A NEW INS. SHE HAD STARTED THE PROCESS TO SWITCH OUT HER SYSTEM AND THEN ENDED UP RELOCATING. FOLLOW-UP INFORMATION RECEIVED REPORTED THE REP RE-EDUCATED THE PATIENT ON RECHARGING AND COUPLING. THE BATTERY WAS NOT OVERDISCHARGED AND WAS WORKING PROPERLY. THE PATIENT HAD AN APPOINTMENT WITH THE PHYSICIAN ON (B)(6). NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL FOLLOW-UP IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) DID NOT KNOW WHEN HE INITIALLY BECAME AWARE OF THE PROBLEM. THE REP DID NOT HAVE ANY SPECIFIC RECOLLECTION ABOUT THE PATIENT AND BUT REMEMBERED SHE WAS "KIND OF A COMPLICATED CASE." AFTER ONE VISIT, THE PATIENT MOVED AND WAS CONNECTED WITH A DIFFERENT REP AT THE NEW LOCATION. AT THIS POINT, IN TERMS OF WHAT THE PATIENT ACTUALLY NEEDED OR WHAT WAS ACTUALLY DONE FOR THE PATIENT THE REP DID NOT HAVE ANY RECOLLECTION. LATER, IT WAS REPORTED THAT THE PATIENT HAD HER ENTIRE SYSTEM REPLACED (B)(6) 2014 WITH A NEW SYSTEM. THE PATIENT RECEIVED GOOD COVERAGE DURING INTRA-OPERATIVE TESTING AS WELL AS AFTER SURGERY. THE IMPEDANCES WERE WITHIN NORMAL LIMITS. ADDITIONAL INFORMATION WAS REQUESTED. IF RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582507 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 00022 YR Required Intervention