BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 8285369 · Received January 29, 2019

    Report

    Report Number
    3004209178-2019-01925
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    August 19, 2013
    Report Date
    March 19, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377760 LOT# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD 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. 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 FROM A CONSUMER. IT WAS CLARIFIED THAT THE REPORT OF A WIRE BEING LOOSE WAS THAT A WIRE WAS NOT PLUGGED IN. IT WAS NOTED THIS WAS NOTICED BY AN FNP AND A MANUFACTURER REPRESENTATIVE. THE CAUSE OF THE LOOSE WIRE WAS NOT DETERMINED AND IT WAS THE REASON THE PATIENT COULD ONLY FEEL IT IN THEIR KNEES. NOTHING WAS DONE TO RESOLVE THE LOOSE WIRE, AND THE DEVICE STILL RESIDED IN THE PATIENT¿S BACK. IT WAS NOTED THAT IT HAD NOT WORKED SINCE THE PATIENT HAD IT PUT IN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT DID NOT UTILIZE THE STIMULATOR ANYMORE BECAUSE IT WAS INITIALLY PUT IN TO HELP WITH LEG PAIN, AND NOW THEIR PAIN WAS PRIMARILY IN THEIR BACK. IT WAS NOTED THAT THE PATIENT HAD AN ABANDONED QUAD LEAD, AND THAT THEY DID NOT HAVE A ¿LOOSE¿ WIRE; THE LEADS MOST RECENTLY IMPLANTED WERE SECURE AND TESTED OUT WITH IMPEDANCE CHECKS TO VERIFY. IT WAS NOTED THAT THE ABANDONED LEAD WAS FROM A PRIOR IMPLANTATION THAT WAS LEFT SEQUESTERED, AND WAS NOT MEANT TO BE FUNCTIONAL AS PART OF THEIR SPINAL CORD STIMULATION SYSTEM (VERIFIED VIA X-RAYS). THE MANUFACTURER REPRESENTATIVE TRIED THROUGH NEW PROGRAMMING, UNSUCCESSFULLY, TO GET PARESTHESIA COVERAGE TO THE PATIENT¿S NEW AREAS OF PAIN. IT WAS NOTED THE LEAD PLACEMENT WOULD NOT ALLOW THE MANUFACTURER REPRESENTATIVE TO INCORPORATE THESE HIGHER AREAS OF THE BODY, BUT THEY WERE NOT ORIGINALLY PLACED TO TARGET THESE AREAS. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377760, LOT# V012045, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# V011517, PRODUCT TYPE: LEAD. DATE INACCURATE, ONLY THE YEAR IS VALID. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377760, LOT# V012045, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 377760, LOT# V011517, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAS MALFUNCTIONED AND THAT THE DEVICE OR A SIMILAR DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. 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 AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT'S DOCTORS TOLD THE PATIENT THEY HAD A LOOSE WIRE. THEY WERE TOLD THIS ABOUT FOUR MONTHS AGO AND HADN'T RECEIVED ANY FOLLOW UP INSTRUCTIONS. NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. IT AS REPORTED THAT THE REASON FOR ABANDONING THE LEAD WAS NOT DETERMINED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79465 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR