BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 9117316 · Received September 25, 2019

    Report

    Report Number
    3004209178-2019-18360
    Event Type
    Injury
    Date Received
    September 25, 2019
    Date of Event
    September 19, 2019
    Report Date
    February 18, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    'DATE RECEIVED MFR' DATE FOR FOLLOW UP NUMBER 001 SHOULD HAVE BEEN DECEMBER 9, 2019 BASED ON THE NEW INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID: 37714, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 97755, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-65, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37714, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(4) 2019, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 39565-65, SERIAL/LOT #: (B)(4), UBD: 05-JUL-2015, UDI#: (B)(4). 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 REP ON JANUARY 28, 2020. THEY REPORTED THAT THE PADDLE LEAD WAS REPLACED ON (B)(6) 2019. SINCE THE LEAD REPLACEMENT, ALL ISSUES HAD RESOLVED. THE PATIENT WAS NOW CHARGING EVERY 15 OR MORE DAYS AND THEY WERE GETTING EXCELLENT COVERAGE IN THEIR PAIN AREAS. ALSO, ALL EQUIPMENT THE PATIENT WAS USING WAS SUFFICIENT REPORTED TO BE SUFFICIENT AS WELL. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPRESENTATIVE. THEY STATED THAT THEY WERE WITH THE PATIENT TODAY WHO WAS HAVING A REVISION DUE TO THE EARLIER ISSUES. THE PATIENT REPORTED THAT THE DEVICE WAS TAKING LONGER TO RECHARGE THAN USUAL. THEIR RECHARGE DIARY SHOWED AVERAGE QUALITY WAS EXCELLENT AND IT WOULD STILL TAKE PATIENT ABOUT AN HOUR AND A HALF TO RECHARGE FROM 30-40%. CALLER CONFIRMED THAT PATIENT DOES NOT CHARGE WHILE CONTROLLER SCREEN WAS ILLUMINATED. THEIR CHARGE QUALITY SHOWED 'EXCELLENT'. THE CALLER WAS NOT CURRENTLY CHARGING BUT STATES THAT PATIENT'S LAST 10 CHARGES SHOWED EXCELLENT. THEY REVIEWED THAT A NEW ANTENNA MAY NOT AFFECT CHARGING TIMES AS 1.5 HOURS IS NORMAL FROM 0 TO FULL WHEN FOLLOWING BEST PRACTICES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL. THEY STATED THAT THE CAUSE OF HAVING TO CHARGE MORE FREQUENTLY WAS DETERMINED TO BE THAT THE PADDLE LEAD HAD A PARTIAL MALFUNCTION. ONE OF THE TWO WIRES (RIGHT SIDED CONTACTS WERE NOT FUNCTIONING). THE ACTIONS TAKEN TO RESOLVE THE HAVING TO CHARGE MORE FREQUENTLY INVOLVED A REVISION SURGERY. THEY HAD THE PADDLE LEAD REPLACED AND THE ISSUE RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) VIA A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT PRIOR TO REPLACEMENT OF THE INS, CONTACTS 12 AND 15 WERE OUT OF RANGE/HIGH IMPEDANCES BUT THE PATIENT HAD PROGRAMS THAT WERE ABLE TO CAPTURE PAIN RELIEF, SO NO REPLACEMENT OF LEAD OR EXTENSIONS WERE DONE. THE REP REPORTED THAT AFTER A WEEK, CONTACT 11 BECAME OUT OF RANGE/HIGH IMPEDANCES, SO IT WAS BECOMING INCREASINGLY MORE DIFFICULT TO CAPTURE RIGHT SIDE RELIEF WITH THE 2 EXISTING CONTACTS ON THE RIGHT SIDE OF THE PADDLE. THE REP REPORTED THAT THERE WAS A LOSS IN PAIN COVERAGE DUE TO CONTACT BECOMING OUT OF RANGE. THE REP REPORTED THAT REPROGRAMMING WAS DONE AND THE DOCTOR WAS CONSULTED ON (B)(6) 2019. THE ISSUE WAS NOT RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910856 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention