BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 7575154 · Received June 6, 2018

    Report

    Report Number
    3004209178-2018-12772
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    May 21, 2018
    Report Date
    October 5, 2018
    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
    MN, 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

    DATE IS APPROXIMATE. 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.

    Additional Manufacturer Narrative · 1

    DUE TO IMDRF HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES NO LONGER APPLY TO THIS EVENT. 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 CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FAILED BACK SURGERY SYNDROME AND SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT WAS PROGRAMMED WITH ADAPTIVE STIMULATION (AS) RECENTLY FOR UPRIGHT, LYING/LEFT SIDE, LYING/RIGHT SI DE, AND SHORTLY AFTER THAT THE PATIENT HAD SO MUCH TINGLING IN THEIR BACK, ACROSS THE MIDDLE OF THE BACK ON THE RIGHT SIDE WHEN UPRIGHT. THE PATIENT STATED THAT THERE WAS A SORE SPOT, THEY COULD HARDLY TOUCH IT, AND IT WAS THROBBING. THE PATIENT NOTED TAKING A HYS INGLA/24 HOUR PAIN MEDICATION AND MAY HAVE TO TAKE A HYDROCODONE. THE PATIENT SAID THEY TRIED TO TURN THE INS OFF BUT IT WAS BACK ON IN 5 MINUTES. ON THE CALL THE PATIENT PROGRAMMER SHOWED THAT STIMULATION WAS ON AT 1.00V. THE PATIENT LOWERED THE AMPLITUDE AND STA TED IT WAS BETTER BUT STILL NOT COMFORTABLE. THE PATIENT THEN LOWERED TO 0.00, WHICH THE PATIENT STATED WAS WORSE, SO THEY INCREASED AND CHOSE 0.50V, WHICH THE PATIENT STATED THEY WILL TRY BECAUSE IT WAS BETTER. THE PATIENT CONFIRMED THAT THE AS LEARNED THE NEW AMPLITUDE SETTING. NO DEVICE ISSUES WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THEY HAD NOT BEEN SURE HOW TO TURN DOWN THE VOLTAGE FOR THE STANDING SETTING. THEY TRIED TURNING THE VOLTAGE DOWN BUT THAT DID NOT WORK FOR THEM. THEY WERE SCHEDULED FOR A REPROGRAMMING APPOINTMENT FOR (B)(6) 2018. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER. IT WAS REPORTED THAT A MANUFACTURER'S REPRESENTATIVE ASSISTED THEM WITH PROGRAMMING THEIR DEVICE; HAD TO GO 2 WEEKS. PATIENT REPORTED THE REP HELPED WITH CONTINUOUS THROBBING, HOWEVER, THEY ARE STILL NEEDING MULTIPLE PAIN MEDS ARE SUGGESTING A PAIN PUMP. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER. IT WAS REPORTED THAT THE PROGRAM WAS NOT CHANGED ACCIDENTLY. HCP STATED SHE RETURNED IT A WEEK LATER AND IT WAS SORTED OUT. IT WAS REPORTED NOW A 0.5V INSTEAD OF 1.0V. IT WAS REPORTED THAT THE TINGLING IN BACK/ SORE SPOT/ THROBBING HAS DECREASED HOWEVER STILL PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417135 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR