BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 11878363 · Received May 25, 2021

    Report

    Report Number
    3004209178-2021-08292
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    April 23, 2021
    Report Date
    November 23, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315467
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: PRODUCT ID: 97715 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. THE IMPLANTABLE NEUROSTIMULATOR (INS) PASSED FUNCTIONAL TESTING; HOWEVER FOREIGN MATERIAL WAS OBSERVED IN THE IMPLANTABLE NEUROSTIMULATOR (INS) CONNECTOR PORT. 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.

    Description of Event or Problem · 0

    2021-APR-23 MPXR 831905 (CON, REP): INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE (REP) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT CONNECTIONS 10-15 WERE NOT CONNECTED PROPERLY. THIS CAUSED REP NOT TO BE ABLE TO OBTAIN PROPER PARATHESIA COVERAGE WHEN TURNING ON IMPLANT TO PROGRAM. INTERROGATED DEVICE AND RAN BOTH CONNECTION CHECK AND IMPEDANCE CHECK. TRIED REPROGRAMMING WITH ELECTRODES THAT WERE AVAILABLE AND USED INTELLISTIM TO REMAP LEAD TO SEE IF PROPER COVERAGE COULD BE OBTAINED. THE ISSUE IS NOT RESOLVED. SURGICAL INTERVENTION IS PLANNED. E1 (REP) ADDITIONAL INFORMATION RECEIVED. REP RESPONDED AND REPORTED NO ISSUE SURGICALLY. OK IMPLANT ALL CONNECTIONS WERE IN A GOOD STATUS. SURGICAL INTERVENTION IS PLANNED BUT NOT YET SCHEDULED 2021-04-29 MPXR 831905.1: THE REP REPORTED THAT THE INS WAS REPLACED ON (B)(6) 2021. 2021-04-30 E2: NO NEW INFORMATION. 2021-MAY-04 RP (REP): NO NEW INFORMATION. 2021-MAY-10 E3, E4 (REP): NO NEW INFORMATION. 2021-MAY-18 TELPH (REP): IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS ELECTIVELY REPLACED BY DOCTOR TO AVOID ANY FUTURE ISSUES, THERE WERE NO ISSUES WITH THE OLD DEVICE. THE OLD DEVICE WAS SENT BACK. A NEW DEVICE WAS PLACED ON(B)(6) 2021 AND ALL CONNECTIONS AND EVERYTHING WORKED FINE. REP WAS PRESENT AT REPLACEMENT; NO ISSUES NOTED. HOWEVER, PATIENT HAD A FOLLOW-UP APPOINTMENT WITH ANOTHER REP AND THAT WAS WHEN ISSUES WERE NOTED. 2021-AUG-24 RTG0205901 (CON): NO NEW INFORMATION 2021-MAY-25 TELPH1 (REP): ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. HE STATED THAT THE DEVICE RETURNED, WAS THE DEVICE WITH CONNECTION ISSUES AS THE ISSUE RESOLVED AFTER ITS REPLACEMENT. EVERYTHING IS WORKING FINE FOR PATIENT AFTER (B)(6) 2021 SURGERY.

    Additional Manufacturer Narrative · 1

    ANALYSIS NOT AVAILABLE AT THIS TIME. AN UPDATE WILL BE SUBMITTED WHEN INFORMATION BECOMES AVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE (REP) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT CONNECTIONS 10-15 WERE NOT CONNECTED PROPERLY. THIS CAUSED REP NOT TO BE ABLE TO OBTAIN PROPER PARASTHESIA COVERAGE WHEN TURNING ON IMPLANT TO PROGRAM. INTERROGATED DEVICE AND RAN BOTH CONNECTION CHECK AND IMPEDANCE CHECK. TRIED REPROGRAMMING WITH ELECTRODES THAT WERE AVAILABLE AND USED INTELLISTIM TO REMAP LEAD TO SEE IF PROPER COVERAGE COULD BE OBTAINED. THE ISSUE IS NOT RESOLVED. SURGICAL INTERVENTION IS PLANNED. ADDITIONAL INFORMATION RECEIVED. REP RESPONDED AND REPORTED NO ISSUE SURGICALLY. OK IMPLANT ALL CONNECTIONS WERE IN A GOOD STATUS. SURGICAL INTERVENTION IS PLANNED BUT NOT YET SCHEDULED. THE REP REPORTED THAT THE INS WAS REPLACED ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS ELECTIVELY REPLACED BY DOCTOR TO AVOID ANY FUTURE ISSUES, THERE WERE NO ISSUES WITH THE OLD DEVICE. THE OLD DEVICE WAS SENT BACK. A NEW DEVICE WAS PLACED ON (B)(6) AND ALL CONNECTIONS AND EVERYTHING WORKED FINE. REP WAS PRESENT AT REPLACEMENT; NO ISSUES NOTED. HOWEVER, PATIENT HAD A FOLLOW-UP APPOINTMENT WITH ANOTHER REP AND THAT WAS WHEN ISSUES WERE NOTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. HE STATED THAT THE DEVICE RETURNED, WAS THE DEVICE WITH CONNECTION ISSUES AS THE ISSUE RESOLVED AFTER ITS REPLACEMENT. EVERYTHING IS WORKING FINE FOR PATIENT AFTER (B)(6) SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773716 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention "SEE H10...."