BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 6552922 · Received May 8, 2017

    Report

    Report Number
    3004209178-2017-09889
    Event Type
    Injury
    Date Received
    May 8, 2017
    Date of Event
    December 6, 2016
    Report Date
    May 8, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 977C165, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN VIA A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT FELL AND LANDED ON HER FACE, FRONT HARD. THE REP REPORTED THAT THE PATIENT BROKE HER RIBS IN THE FRONT AND BACK RIBS. THE REP REPORTED THAT AFTER THE FALL, THE PATIENT HAD A LOT OF INTERNAL SWELLING AND NEEDED AN MRI. THE REP REPORTED THAT THE PHYSICIAN HAD THE PATIENT ON STEROIDS AND SENT THE PATIENT TO PHYSICAL THERAPY; THEREFORE, NO REP COULD CHECK THE DEVICE. THE REP REPORTED THAT THE PATIENT WAS SEEN BY A REP ON (B)(6) 2017 AND ATTEMPTED TO TURN STIMULATION ON BUT COULD NOT GET TO THE AREA WHERE THE PATIENT WAS BEFORE. THE REP REPORTED THAT THE PATIENT WAS SEEN FOR REPROGRAMMING AGAIN ON (B)(6) 2017. THE REP REPORTED THAT SHE TRIED TO USE ALL ELECTRODE CONTACTS BUT ONLY ABLE TO GET RIBCAGE STIMULATION. THE REP REPORTED THAT WHEN USING THE BOTTOM OF THE LEAD, ONLY GETTING STIMULATION IN THE PATIENT¿S ARMS. THE REP REPORTED THAT PROGRAMMING USING THE MIDDLE OF THE LEAD AND UP, ONLY STIMULATION THE RIBS. THE REP REPORTED THAT ELECTRODE IMPEDANCE WAS PERFORMED AT 0.7V AND ALL CONTACTS WERE WITHIN 1200-1300 OHMS. REFERENCE 0: 5: 3165 OHMS 11: 4152 OHMS 12: 1162 OHMS. REFERENCE 5: 11: 6000 OHMS THE REP REPORTED THAT THE PHYSICIAN HAD PERFORMED AP VIEW AND LOCATION OF THE LEAD WAS THE SAME. THE REP REPORTED THAT THE PATIENT NEEDED THE DEVICE FOR LOWER BACK AND LEFT SIDE WORSE THAN THE RIGHT SIDE. THE REP REPORTED THAT REPROGRAMMING WAS TRIED USING BIPOLAR PAIRS: 5,8 = CALLER REPORTS PATIENT FEELS IN LEFT RIB LEFT AND MID STOMACH 2+,3- = CALLER REPORTS PATIENT FEELS IN LEFT SIDE, DOWN TO LEG AND ARMPIT ON LEFT SIDE. 2-3+ = CALLER REPORTS PATIENT FEELS IN LEFT SIDE, RIB ARMPIT TO KNEE LEFT SIDE 4,10 = CALLER REPORTS PATIENT FEELS IN RIB AREA 0-,5+ = CALLER REPORTS SHE INCREASED UP TO 10.5V, PATIENT IS NOT FEELING STIMULATION. 5,11 = CALLER REPORTS SHE INCREASED UP TO 10.5V, PATIENT IS NOT FEELING STIMULATION. 10,15 = CALLER REPORTS PATIENT FEELS IN RIB AND LEGS AT 8V 3,4 = CALLER REPORTS PATIENT FEELS IN RIBS AT 2.8V 2-,13+ = CALLER REPORTS PATIENT FEELS IN LEFT RIB AT 7.9V THE REP THEN RECHECKED ELECTRODE IMPEDANCE AND ALL CONTACTS WERE 1100-1200 OHMS. REFERENCE 0: 5: 2515 OHMS 11: 3824 OHMS THE REP REPORTED THAT THE FALL THE PATIENT HAD ON (B)(6) 2016 COULD BE RELATED TO THIS ISSUE. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE STIMULATION WORKED BEFORE THE FALL AND AFTER THE FALL IT WAS NOT WORKING PROPERLY. IT WAS STATED THAT TROUBLESHOOTING WAS DONE ON THE PHONE AND TO RESOLVE THE IMPEDANCE AND STIMULATION IN THE WRONG LOCATION THE PHYSICIAN HAD DECIDED TO EXPLANT THE DEVICE. NO FURTHER COMPLICATIONS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333047 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention