BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3840997 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09908
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 16, 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

    PRODUCT ID 3888-33, LOT# V643872, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3888-33, LOT# V643872, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3888-33, LOT# V643872, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37744, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN A CAR ACCIDENT LAST YEAR ON (B)(6). THE PATIENT STATED THAT EVER SINCE THE CAR ACCIDENT THE STIMULATION DEVICE HAD ¿NOT WORKED.¿ THE PATIENT STATED THAT THEY MET THE MANUFACTURER REPRESENTATIVE IN FEBRUARY TO HAVE THE DEVICE ¿JUMP STARTED¿ AND ¿HALFWAY¿ THROUGH THE JUMP START/AFTER THREE HOURS THE MANUFACTURER REPRESENTATIVE SENT THE PATIENT HOME. THE PATIENT STATED THAT THE BATTERY WAS COMPLETELY CHARGED. THE PATIENT STATED THAT WHEN THEY TRIED TO TURN STIMULATION ON WITH THE PATIENT PROGRAMMER THEY OBSERVED A POWER ON RESET (POR) MESSAGE. THE PATIENT NOTED THAT THEY CONTACTED THE MANUFACTURER REPRESENTATIVE AND THEY WERE NOT ABLE TO CLEAR THE POR OVER THE PHONE. THE PATIENT STATED THAT THE MANUFACTURER REPRESENTATIVE ¿HAD BEEN TOO BUSY TO MEET.¿ THE PATIENT NOTED THAT AS OF 2015 (B)(6) THE RECHARGER WAS NOT COMMUNICATING WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT NOTED THAT THE BATTERY DEPLETED QUICKLY AFTER IT WAS JUMP STARTED. THE PATIENT ALSO MENTIONED THAT THEY HAD SURGERY ONE WEEK AFTER THE CAR ACCIDENT AND THE PATIENT ASPIRATED DURING THE SURGERY AND WAS ON A FEEDING TUBE. THE PATIENT STATED THAT THEY KEPT IN CONTACT WITH THE MANUFACTURER REPRESENTATIVE SO THAT THE MANUFACTURER REPRESENTATIVE WOULD KNOW THE PATIENT¿S CONDITION. LATER IN THE SAME DAY, THE MANUFACTURER REPRESENTATIVE CALLED AND STATED THAT THIS WAS A ¿PROBLEM PATIENT.¿ LATER THE SAME DAY, IT WAS REPORTED THAT A POSSIBLE PROBLEM WITH THE INS WAS REVIEWED/SUSPECTED/ALLEGED. IT WAS NOTED THAT THE PATIENT AGAIN MENTIONED THAT SINCE THE CAR ACCIDENT IN (B)(6), THE STIMULATOR HAD NOT WORKED. THE PATIENT NOTED THAT IT WORKED FINE UNTIL THE CAR ACCIDENT. THE PATIENT NOTED THAT THEY ¿JUST COULD NOT HANDLE THE PAIN¿ SINCE THE CAR ACCIDENT. THE PATIENT MET THE MANUFACTURER REPRESENTATIVE AT THE DOCTOR¿S OFFICE AND THE MANUFACTURER REPRESENTATIVE HELPED JUMP START THE PATIENT¿S BATTERY. THE PATIENT NOTED THAT THE DEVICE DID WORK FOR THEM AND THE PATIENT HAD BEEN ABLE TO ELIMINATE THREE ¿PAIN MEDS¿ BECAUSE OF THE DEVICE. THE PATIENT MENTIONED THAT AFTER THE ACCIDENT, THE PATIENT WENT TO SURGERY AT UCSF BECAUSE OF ¿NECK INJURY¿, HAD PREVIOUS NECK INJURIES AND IT ¿CAUSED MORE DAMAGE.¿ IT WAS NOTED THAT THEN THE PATIENT WENT INTO SURGERY A WEEK AFTER THE ACCIDENT, ASPIRATED AND THEN HAD FEEDING TUBES AND PNEUMONIA. WHEN THE PATIENT BECAME BETTER THEY MET WITH THE MANUFACTURER REPRESENTATIVE IN FEBRUARY AND THEY JUMP STARTED THE BATTERY. THE PATIENT THEN RECHARGED THE BATTERY AND OBSERVED THE POR CODE. THE PATIENT STATED THAT THE MANUFACTURER REPRESENTATIVE TRIED TO CLEAR THE POR BUT ¿IT WOULD NOT CLEAR.¿ THE PATIENT NOTED THAT WHEN THEY GOT HOME THEY HAD CALLED THE MANUFACTURER REPRESENTATIVE BUT ¿THEY COULD NOT CLEAR IT.¿ THE PATIENT ALSO MENTIONED THAT THEY HAD BECOME ¿SICK¿ AND THE PATIENT¿S HUSBAND STAYED HOME TO TAKE OF THEM. THE PATIENT MENTIONED THAT FOR THE ¿PAST THREE YEARS¿ ONE DOCTOR WOULD NOT ALLOW THE PATIENT TO MAKE APPOINTMENTS DUE TO INSURANCE ISSUES. THE DOCTOR THAT DID NOT ALLOW APPOINTMENTS WAS THE DOCTOR THAT IMPLANTED THE DEVICE. THE PATIENT STATED THAT IF ¿THIS¿ DID NOT GET RESOLVED THEY WOULD SEE A DIFFERENT DOCTOR. THE PATIENT ALSO NOTED THAT WHEN THEY HAD ¿PROBLEMS¿ WITH THE DEVICE THIS DIFFERENT DOCTOR COULD NOT ¿DO ANYTHING¿ BECAUSE THEY WERE NOT THE ONE THAT SURGICALLY IMPLANTED IT. THE PATIENT NOTED THAT THEY HAD AN APPOINTMENT WITH THIS DOCTOR ON 2014 (B)(6). THE PATIENT LEFT A MESSAGE WITH THE DOCTOR¿S OFFICE TO SEE IF THE MANUFACTURER REPRESENTATIVE COULD MEET AT THE OFFICE. THE PATIENT NOTED THAT THE MANUFACTURER REPRESENTATIVE ¿HAD BEEN HELPFUL AND VERY COMPASSIONATE.¿ THE PATIENT NOTED THAT THE MANUFACTURER REPRESENTATIVE ¿WAS NEVER NEGATIVE OR RUDE.¿ THE PATIENT WISHED THAT ¿EVERYONE COULD BE LIKE THE [MANUFACTURER REPRESENTATIVE].¿ LATER THE SAME DAY, IT WAS REPORTED THAT AFTER THE PATIENT CALLED IN THE FIRST TIME THEY HAD TEXTED THE MANUFACTURER REPRESENTATIVE AND EXPLAINED THE SITUATION TO THE MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT¿S STIMULATOR WAS OFF, ¿NOT WORKING¿ AND BELIEVED TO BE IN OVERDISCHARGE. IT WAS NOTED THAT THE PATIENT WAS PLACED ON FEEDING TUBES FROM (B)(6). IN (B)(6), THE PATIENT WAS WELL ENOUGH TO SEE THE MANUFACTURER REPRESENTATIVE FOR A FORCED RECHARGE OF THE IMPLANT. AT THIS TIME THE MANUFACTURER REPRESENTATIVE ASSISTED WITH A PHYSICIAN MODE RECHARGE (PMR) AND THE PATIENT WAS INSTRUCTED TO FINALIZE THE PMR AT HOME. WHEN THE PATIENT WAS HOME THEY OBSERVED THE POR CALL DOCTOR SCREEN. HOWEVER, THE POR COULD NOT BE CLEARED WITH THE PATIENT PROGRAMMER. THE POR WAS NEVER CLEARED AND THE PATIENT WAS IN OVERDISCHARGE AGAIN AS OF 2014 (B)(6). THE PATIENT MENTIONED THAT THEY BECAME SICK AGAIN IN (B)(6) HAD PNEUMONIA ¿TWICE AGAIN¿ AND WAS BED BOUND. THE PATIENT STATED THAT FOR THIS REASON THEY HAD NOT BEEN ABLE TO FOLLOW-UP ON A PMR OR ¿ISSUE¿ BUT WANTED STIMULATION BACK. THE PATIENT INDICATED THAT WHEN THE IMPLANT WAS ON AND WORKING IT ¿REALLY WORKED WELL¿ FOR THE PAIN AND THEY WERE AMAZED. THE PATIENT NOTED THAT THEY WERE OFF THREE STRONG PAIN MEDICATIONS BUT WAS BACK ON THE MEDICATIONS BECAUSE THEY DID NOT HAVE THE STIMULATOR TO HELP OUT. THE MANUFACTURER REPRESENTATIVE INDICATED THAT THEY WERE AWARE THAT THE PATIENT WAS IN OVERDISCHARGE AND THAT THEY HAD TRIED TO SCHEDULE ¿NUMEROUS¿ FOLLOW-UP APPOINTMENTS WITH THE PATIENT TO GET THE OVERDISCHARGE RESOLVED. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN COOPERATIVE WITH THE FOLLOW-UP APPOINTMENTS. THE MANUFACTURER REPRESENTATIVE INDICATED THAT THEY WOULD WORK TOWARDS BEING AT THE 2014 (B)(6) APPOINTMENT WITH THE DOCTOR THE MONDAY AFTER 2014 (B)(6). LATER ON 2014 (B)(6), THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT HAD MULTIPLE APPOINTMENTS AND THEY WERE SUPPOSED TO COME AND MEET THE MANUFACTURER REPRESENTATIVE TO HAVE THE POR CLEARED BUT THE PATIENT MISSED ALL OF THESE APPOINTMENTS. THE MANUFACTURER REPRESENTATIVE STATED THAT THE BATTERY DID NOT STOP WORKING DUE TO AN ACCIDENT. RATHER, IT WAS NOT WORKING BECAUSE, THE PATIENT REFUSED TO MEET WITH THE MANUFACTURER REPRESENTATIVE TO HAVE THE POR CLEARED. THE MANUFACTURER REPRESENTATIVE STATED THAT THEY HAD FOLLOWED UP WITH THE DOCTOR MULTIPLE TIMES AND THOUGHT THE PATIENT HAD AN APPOINTMENT COMING UP. THE MANUFACTURER REPRESENTATIVE STATED THAT THEY WERE GOING TO TRY TO BE AT THAT APPOINTMENT. THE MANUFACTURER REPRESENTATIVE NOTED THAT THE PATIENT WAS NOT RELIABLE AND THERE WAS NOT MUCH THAT THEY COULD DO OTHER THAN BE AT THE APPOINTMENTS THAT WERE SCHEDULED. THE MANUFACTURER REPRESENTATIVE HAD NO ADDITIONAL INFORMATION TO PROVIDE. SEE REPORT # 3004209178-2013-06270 WHICH RELATED TO THE SAME DEVICE AND THE AUGUST CAR ACCIDENT WAS ALSO MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317866 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR