BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 4

    MDR report key: 8203513 · Received December 28, 2018

    Report

    Report Number
    3004209178-2018-28488
    Event Type
    Injury
    Date Received
    December 28, 2018
    Date of Event
    October 4, 2018
    Report Date
    August 5, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS #241836423:ANALYSIS INFORMATION (B)(6) 2019 08:11:26 CST PLI# 10 PRODUCT ID# 37703 BELOW IS UNEDITED, SYSTEM GENERATED TEXT BASED ON THE ANALYSIS FINDING CODE(S). THE RETURNED DEVICE WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDE BUT IS NOT LIMITED TO VISUAL INSPECTION, OUTPUT AND TELEMETRY TESTING, AND FUNCTIONAL TESTING. ANALYSIS DETERMINED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) OUTPUT AND TELEMETRY WERE ACCEPTABLE; HOWEVER, THE BATTERY WAS NEAR NORMAL BATTERY DEPLETION. H3: THE INS WAS RECEIVED IN AN EOS CONDITION. THE INS BATTERY WAS AT 2.11 VOLTS. AFTER RESETTING THE EOS BIT AND IPG INACTIVE BITS WITH THE LAB PROGRAMMER, THERE WAS GOOD OUTPUT AND TELEMETRY. DESTRUCTIVE ANALYSIS OF THE INS WAS PERFORMED TO CHECK THE HYBRID AND BATTERY FOR ANY POSSIBLE HIGH CURRENT DRAIN CONDITION. NO VISUAL OR ELECTRICAL ANOMALIES WERE FOUND WITH THE HYBRID CIRCUIT. DESTRUCTIVE ANALYSIS DID NOT REVEAL ANY INTERNAL ANOMALIES THAT WOULD HAVE CAUSED A HIGH CURRENT CONDITION OR EARLY BATTERY DEPLETION. A LONGEVITY ESTIMATE BASED ON THE PARAMETERS THE INS HAD WHEN RECEIVED FOR ANALYSIS, INDICATED AN EXPECTED LIFE OF APPROXIMATELY 1.8 YEARS TO EOS. ACCORDING TO THE TRACE REPORT TAKEN FROM THE INS, THE BATTERY DEPLETED TO EOS IN 3.57 YEARS (B)(6) 2015 TO (B)(6)2018).ANALYSIS EQUIPMENT USED ON THIS PE:161267 OSCILLOSCOPE,ES060544 LOAD RESISTANCE BOX,ES045514 LOAD RESISTANCE BOX,ES060547 LOAD RESISTANCE BOX,ES045515 LOAD RESISTANCE BOX,113249 WARMING OVEN,110160 POWER SUPPLY MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT¿S HEALTHCARE PROVIDER REPORTED VIA MANUFACTURE REPRESENTATIVE THAT THE PATIENT FELT HEAT COMING FROM THE INS AND THEN IT WAS AT END OF SERVICE (EOS). THE SETTINGS WERE REPORTED TO HAVE BEEN: 0-1-2- IPG +, DI 350 MICROS, N 60HZ AND INT 1,8 V. NO ENVIRON MENTAL/EXTERNAL/PATIENT FACTORS WERE NOTED THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE INS WAS REPLACED AND THE IMPEDANCES WERE OK. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043854 ITREL 4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37703

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention