BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6744726 · Received July 26, 2017

    Report

    Report Number
    3004209178-2017-15606
    Event Type
    Malfunction
    Date Received
    July 26, 2017
    Date of Event
    April 20, 2017
    Report Date
    February 11, 2019
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD, PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(4) 2016, PRODUCT TYPE: LEAD. H6: DUE TO IMDRF HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES NO LONGER APPLY TO THIS EVENT. DEVICE EVALUATION CONCLUSION CODE 67 PERTAINS TO LEAD 977A260 5MM COMPACT 1X8 MRI (B)(4) AND LEAD 977A260 5MM COMPACT 1X8 MRI (B)(6). 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 FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THE PATIENT WAS REPROGRAMMED 6 TIMES AND NO ACTION TAKEN WITH THE LEAD MIGRATION AS IT WAS TAKEN INTO CONSIDERATION WITH REPROGRAMMING. THE HCP STATED THE REPROGRAMMING TAKE PLACE ON (B)(6) 2017, AND (B)(6) 2018. THE HCP STATED THE PATIENT WAS GIVEN MEDROL DOSE PACK ON (B)(6) 2017. THE PATIENT HAD A LUMBAR EPIDURAL STEROID INJECTION (ESI) ON (B)(6) 2017. THE PATIENT HAD A CAUDAL ESI ON (B)(6) 2018. THE PATIENT HAD A NERVE BLOCK ON (B)(6), 2018. THE PATIENT HAD A LUMBAR INJECTION ON (B)(6) 2018 AND (B)(6) 2019. THE HCP NOTED THE PAIN LEVELS CONTINUED AT 9-10 LEVEL REGARDLESS OF REPROGRAMMING. THE HCP NOTED THAT SPINAL INJECTION NEUROTOMY SEEMED TO HELP THE MOST. THE HCP STATED THE PAIN LEVELS ON (B)(6) 2018 WERE 5-5-5. THE HCP NOTED THERE WAS NO FURTHER ACTION PLANNED IN REGARD TO THE LEADS, IT WAS RESOLVED. THE HCP NOTED CONTINUED TREATMENT FOR PAIN WITH NO FURTHER ACTION PLANNED AS OF (B)(6) 2019. THE HCP NOTED THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) OF A CLINICAL STUDY REPORTING THAT THE OUTCOME OF THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL AS PART OF A CLINICAL STUDY, REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT HAD A SPINAL CORD STIMULATOR IN SITU THAT WAS DOING VERY WELL WITH PAIN RELIEF. THE PATIENT REPORTED ON (B)(6) 2017, THAT SHE NOTICED A LOSS OF PAIN RELIEF ON (B)(6) 2017. IMAGING WAS DONE ON (B)(6) 2017, AND THE IT WAS FOUND THAT THE PATIENT¿S LEADS MIGRATED. THE ENTIRE SYSTEM WAS REPROGRAMMED ON (B)(6) 2017. IT WAS NOTED THAT THE EVENT RESULTED IN AN UNSCHEDULED CLINIC OR OFFICE VISIT. THE EVENT WAS ONGOING. THE ETIOLOGY WAS NOT RELATED TO THE IMPLANT PROCEDURE, BUT RELATED TO THE DEVICE OR THERAPY, SPECIFICALLY THE LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526125 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