BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 8005668 · Received October 25, 2018

    Report

    Report Number
    3004209178-2018-23912
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Date of Event
    September 1, 2018
    Report Date
    November 5, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109490
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT HAD AN INCREASE IN PAIN. THE PATIENT HAD A BURNING SENSATION WITH STIMULATION OFF BUT THE BURNING SENSATION WORSENED WITH STIMULATION ON. THIS HAD GOTTEN WORSE THE LAST MONTH ((B)(6) 2018). IMPEDANCES WERE TESTED AND SHOWED THE FOLLOWING RESULTS: 1 16858 OHMS 2 23066 3 26365 4 22731 5 7109 6 23367 7 40K 8 10006 9 8004 10 40K 11 8048 12 9236 13 25301 14 40K 15 8219 OHMS THE PATIENT USED GROUP B WITH PROGRAM 1 WITH 13, 14, 15, 8-, 9- AT 2.6 V AND WITH PROGRAM 2 WITH 8, 9, 10 AT 3.8V. THE PATIENT WAS REPROGRAMMED TO USE GROUP C. GROUP C PROGRAM 1 WAS 4.8V WITH 300 PULSE-WIDTH AND 60 HERTZ AT 1790 OHMS AND 2.754 MA. PROGRAM 2 HAD 6.8V, 300 PULSE-WIDTH AND 60 HERTZ AND 1345 OHMS AND 5.116 MA. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THE PATIENT WAS THE FIRST PERSON TO INFORM THEM OF THE REPORTED EVENT. IT WAS REPORTED THE REPROGRAMMING THE PATIENT TO GROUP C RESOLVED THE INCREASED PAIN AND WORSENED BURNING SENSATION. THE PATIENT¿S WEIGHT AT THE TIME OF THE EVENT WAS UNKNOWN. IT WAS INDICATED THAT THE PROVIDED INFORMATION HAD BEEN CONFIRMED WITH THE PHYSICIAN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845690 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97713 00643169109490

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR