BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 8044647 · Received November 6, 2018

    Report

    Report Number
    3004209178-2018-24833
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 1, 2017
    Report Date
    January 2, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994610430
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: 37092, SERIAL#: UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37746, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE DEVICE KEPT TURNING ITSELF UP AND MOST TIME THE PATIENT COULD GET A READING OFF OF THE DEVICE. THEY TRIED TO KEEP TURNING THE STIMULATION DOWN, BUT THEY COULD NOT GET A READING OFF THE DEVICE MOST TIMES. IT WAS VERY UNCOMFORTABLE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37092, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY; PRODUCT ID: 37746, SERIAL# (B)(6), PRODUCT TYPE: PROGRAMMER, PATIENT. EVENT DATE YEAR (2017) VALID ONLY. 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 POSTLAMINECTOMY PAIN. IT WAS REPORTED THAT THE PATIENT PROGRAMMER (PP) HAD POOR COMMUNICATION. THE PATIENT REPORTED THEY NEEDED A NEW PP BECAUSE IT WASN'T WORKING. THEY CLARIFIED THAT THEY GOT POOR COMMUNICATION INTERMITTENTLY. THEY BELIEVED THE STIMULATION WOULD INCREASE ON ITS OWN AND IT WOULD FEEL TOO HIGH, SO THEY NEEDED TO MAKE SURE THEY WERE ABLE TO DECREASE WITH THE PP. THEY WOULD FEEL THE INCREASE IN STIMULATION AND THEN THEY WOULD SEE THE NUMBER HAD INCREASE WHEN THEY CHECKED THE PP. THE PATIENT HAD TALKED WITH THEIR HEALTHCARE PROVIDER. SECURING THE ANTENNA AND SYNCING DID NOT RESOLVE THE ISSUE OF POOR COMMUNICATION WITH AND WITHOUT THE ANTENNA. PLACING THE PP DIRECTLY OVER THE INS AND SYNCING DID NOT RESOLVE THE ISSUE. THE CALLER WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO CHECK THEIR STIMULATOR DUE TO THE INCREASING STIMULATION ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884225 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR