BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2840452 · Received November 20, 2012

    Report

    Report Number
    3004209178-2012-10574
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 24, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3550-39 LOT# N317046, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM A MANUFACTURER REPRESENTATIVE STATED THE PATIENT WAS SEEN IN AN EMERGENCY ROOM DUE TO ¿PAIN AT HIS INS SITE.¿ IT WAS STATED THE PATIENT WAS ¿ADVISED TO TURN OFF HIS INS VOLTAGE AND THEN TURN OFF THE POWER.¿ THE PATIENT WAS ADDITIONALLY ¿ADVISED TO SEE HIS IMPLANTING PHYSICIAN.¿ IT WAS NOTED THAT ¿AS FAR AS THE MANUFACTURER REPRESENTATIVE WAS AWARE¿ THE PATIENT ¿HAD NOT BEEN SEEN NOR FOLLOWED THROUGH WITH HIS PART OF THE EVENT.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION CLARIFIED THAT THE PATIENT WAS TASERED 8 TIMES. THE PATIENT EXPERIENCED A BURNING SENSATION AND THAT THE IMPLANTABLE NEUROSTIMULATOR(INS) SITE HURT. THE INS WAS AT 0 VOLTS AND TURNED OFF BUT STILL FELT THESE SYMPTOMS AND WAS SEEN IN THE ER. THE PATIENT STATED THAT THEY HAD SEEN SOME ¿CALL YOUR DOCTOR¿ CODES BUT COULD NOT RECALL ALTHOUGH THE THOUGHT THEY WERE 540 AND 4504. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL FOLLOW UP INFORMATION REPORTED THAT THE PATIENT WAS TO BE SEEN ON (B)(6) 2013 BY THE HEALTHCARE PROFESSIONAL (HCP) AND MANUFACTURER'S REPRESENTATIVE FOR REPROGRAMMING AND TO EDUCATE THEM ON THEIR NEW DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) CONFIRMED THAT CAUSE OF THE EVENT WAS THAT THE PATIENT WAS TASED BY THE POLICE AND THAT THE INS WAS REPLACED. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED IMPEDANCES WERE WITHIN RANGE. THERE WAS NO MALFUNCTION SEEN OR A CAUSE OF ISSUE DETERMINED. THERE WERE NO INTERVENTIONS TAKEN OR PLANNED. IT WAS ALSO NOTED THERE WAS "NOTHING SIGNIFICANT TO REPORT" ABOUT THE PATIENT OUTCOME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT SHOW UP TO HIS SCHEDULED APPOINTMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT, IS AN INMATE, WAS TAZED AND PASSED OUT ON (B)(6) 2012. IT WAS SUSPECTED DUE TO OVERDISCHARGE. THE PATIENT HAD NOT DONE ANY DIAGNOSTICS. THE PATIENT WAS UNABLE TO COMMUNICATE WITH IMPLANTABLE PULSE GENERATOR (IPG) USING THE PATIENT PROGRAMMER AND WAS UNABLE TO TURN ON IPG. THE PATIENT WAS PLANNING ON SEEING THE PHYSICIAN BUT HAD NOT BEEN SCHEDULED YET. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST THE STIMULATION. IT WAS STATED THAT THE "CALL YOUR DOCTOR" ICON WAS DISPLAYED ON THE PROGRAMMER. IT WAS REPORTED THAT THE PATIENT HAD CHARGED AT THE COMPANY REPRESENTATIVE'S DIRECTION AND HE HAD STIMULATION. IT WAS STATED THAT "THE REPRESENTATIVE TRIED TO DO A LCC WITH THE PATIENT TWICE AND BOTH TIME HE GOT THE CODE 565". IT WAS STATED THE PATIENT HAD A MEETING WITH THE COMPANY REPRESENTATIVE SCHEDULED FOR (B)(6) 2012. TEN DAYS LATER IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION. IT WAS STATED THAT THE PATIENT HAS HAD A BURNING SENSATION AT THE POCKET WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS LOCATED SINCE THE PATIENT WAS "TAZED" ON (B)(6) 2012. THIS DATE CONFLICTS WITH THE INITIAL REPORT THAT STATED THE PATIENT WAS "TAZED" ON (B)(6) 2012. IT WAS NOT CLEAR WHICH DATE WAS CORRECT. IT WAS STATED THAT THE PATIENT WAS "TAZED" ON THE CHEST AREA AND THE INS IMPLANT ON RIGHT BUTTOCK. IT WAS REPORTED THAT THE INS POCKET WAS SWOLLEN, BUT IMPROVING. IT WAS STATED THAT THE STIMULATION WAS "WORKING GREAT" AND THE PATIENT WAS RECEIVING THE PAIN COVERAGE HE NEEDED. IMPEDANCE MEASUREMENTS WERE "NORMAL". WHEN THE STIMULATION WAS OFF AND THE INS WAS PALPITATED IT CAUSED A BURNING SENSATION AT THE INS POCKET. WHEN STIMULATION WAS ON AND THE INS WAS PALPITATED IT CAUSED PAIN TO RADIATE TO HIS UPPER BACK AREA. THE PATIENT WAS GOING TO SEE HIS MANAGING PHYSICIAN FOR FURTHER EVALUATION. FURTHER INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

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