BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6344485 · Received February 20, 2017

    Report

    Report Number
    3004209178-2017-04265
    Event Type
    Malfunction
    Date Received
    February 20, 2017
    Date of Event
    February 12, 2017
    Report Date
    April 20, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER.

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THERAPY WAS TURNING OFF BY ITSELF EVERY TWO HOURS. AN IMPEDANCE CHECK WAS PERFORMED WITH ZERO AS A REFERENCE WITH THE FOLLOWING RESULTS: 0-1256 OHMS, 1-1235 OHMS, 2-1256 OHMS, AND 3-1252 OHMS, 4-1295 OHMS, 5-1252 OHMS, 6-1252 OHMS, 7-1252 OHMS, 8-1199 OHMS, 9-1243 OHMS, 10-1276 OHMS, 11-1304 OHMS, 12-1215 OHMS, 13-1224 OHMS, 14-1224 OHMS, AND 15-1202 OHMS WITH THE CONSUMER BEING PROGRAMMED ON +4 -5 -6 +7. AN IMPEDANCE CHECK WAS PERFORMED WITH FIVE AS A REFERENCE WITH RESULTS ON 6 BEING 714 OHMS AND 7 BEING 805 OHMS. ANOTHER CHECK WAS PERFORMED WITH SEVEN AS A REFERENCE WITH RESULTS ON 5 BEING 805 OHMS AND 6 WAS 714 OHMS. FOLLOWING THIS THE REP. WAS GOING TO SEND THE MANUFACTURER¿S FILE FOR ANALYSIS AND WAS GOING TO TRY AND TAKE NOTE OF THE TIME OF DAY WHEN THERAPY WAS TURNING OFF AND WHEN THEY TURNED IT BACK ON AGAIN. DURING THE CALL IT WAS CONFIRMED WITH THE CONSUMER THAT THERE WAS NO LIGHTNING BOLT WHEN THERAPY WAS OFF AND THEY DIDN¿T TURN THERAPY OFF BY THEMSELVES. IT WAS ALSO CONFIRMED THERE WERE NO TRAUMAS OR FALLS REPORTED THAT COULD BE RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE ON (B)(6) 2017 REPORTING THAT THEY WOULD BE MEETING THE PATIENT ON (B)(6) 2017. THE PATIENT HAD A HISTORY OF OVERDISCHARGE AND POWER ON RESET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT SHOW UP TO THEIR APPOINTMENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE CONSUMER, THE HEALTHCARE PROFESSIONAL (HCP), AND THE REPRESENTATIVE (REP) REGARDING THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2017 BY AN HCP AND A "CS". THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS INTERROGATED AND IT WAS DETERMINED THAT THE PATIENT REMAINED NON-COMPLIANT BY ONLY UTILIZING HER DEVICE LESS THAN 10% OF THE TIME. THE PATIENT TOLD HER HCP THAT SHE NEVER SHUT OFF THE SYSTEM. THE PATIENT'S CHARGING SYSTEM SEEMED TO BE WORKING PROPERLY AS HER INS WAS 3/4 CHARGED. WHEN CONNECTED TO THE INS, THEY COULD EASILY OBTAIN 8 BARS REPETITIVELY. THE HCP FELT THAT THE PATIENT WAS TOO NON-COMPLIANT AND WAS CONSIDERING EXPLANT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT SINCE (B)(6) 2017, THE PATIENT'S THERAPY WAS TURNING ITSELF OFF EVERY TWO HOURS. THE PATIENT PROGRAMMER INDICATED THE INS WAS OFF. IT WAS UNKNOWN IF THE PATIENT HAD CYCLING PROGRAMMED INTO THEIR DEVICE. THE PATIENT WAS SCHEDULED TO MEET WITH THE MANUFACTURER REPRESENTATIVE (REP) ON (B)(6) 2017. NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126272 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR