BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 8370568 · Received February 26, 2019

    Report

    Report Number
    3004209178-2019-03994
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    December 27, 2016
    Report Date
    February 28, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THE EVENT: (B)(6) 2016 IS AN ESTIMATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3389S-40, LOT# VA1AC5Z, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AFTER IMPLANT AND THE EXTENSION WAS REPLACED. REP CLARIFIED THAT THE 37086 EXTENSION WOULD NEED TO BE PLUGGED INTO A 37081 EXTENSION, WHICH WOULD THEN GO INTO THE INS. THE POTENTIAL ISSUE WITH THE BALL SEAL ON THE SCS WITH THE DBS PRODUCT GOING INTO IT WAS REVIEWED FOR THE REP. THE REP CALLED BACK AND REVIEWED WHY 3550-05 WOULD NOT BE AN OPTION; ALSO HAD DISCUSSION AROUND IMPEDANCES WITH DAISY-CHAINED EXTENSIONS. THE REP CALLED BACK AGAIN TO DISCUSS THE USE OF 37081 EXTENSION WHEN BEING CONNECTED TO 37086, AND IT WAS REVIEWED FOR THE REP AGAIN THAT THIS NOT ON-LABEL USE. DISCUSSED TUNNELING (3550-38/60), REVIEWED IMPEDANCES AND REVIEWED MRI COMPATIBILITY WOULD LIKELY BE NOT RECOMMENDED OR AT MOST CONSERVATIVE AS HEAD ONLY BUT THAT WILL HAVE TO HEALTH CARE PROFESSIONAL (HCP) DECISION MOVING FORWARD. IT WAS REVIEWED FOR THE REP WHERE TO DOCUMENT NOTES REGARDING THIS UNIQUE SET UP FOR THIS PATIENT. REP CONFIRMED THAT THE HCP WAS CHANGING INS POCKET FROM LEFT CHEST TO RIGHT CHEST AND WILL BE TUNNELING ACROSS THE CHEST. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ANTICIPATED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE (REP) FURTHER REPORTING ON THIS EVENT STATING THAT THE DOCTOR WAS GOING TO MOVE THE INS FROM THE LEFT CHEST TO RIGHT CHEST BUT NOT CHANGING THE EXTENSION. THEY WERE GOING TO DAISY CHAIN WITH AN SCS EXTENSION. AFTER OPENING THE POCKET OF THE INS THEY SAW THE INFECTION BUT THE PATIENT TOLD THEM NOT TO EXPLANT ANYTHING AT THE TIME. NO CONSENT. THEY CLEANED IT OUT, TREATED IT WITH ANTIBIOTICS AS WELL AS WILL GIVE IN ABT AFTER. THEY REPLACED THE INS WITH THE NEW INS AND KEPT IT ON LEFT SIDE OF THE CHEST. THEY DIDN'T WANT TO TUNNEL TO RIGHT CHEST AS A POSSIBLE RISK OF EXPOSING THAT TISSUE TO A POSSIBLE INFECTION. TO ADD TO IT, THEY HAVE NO FAMILY THERE TO HELP. ALSO THEY MAY BE MOVING TO (B)(6) SOON TO BE CLOSER TO FAMILY. THE DOCTOR SUSPECTED THEY MAY NEED TO EXPLANT ENTIRE SYSTEM IN THE FUTURE IF THE INFECTIONS DO NOT GET CONTROLLED. THEY DID SEVERAL CULTURES TODAY. THEY WERE NOT MADE AWARE OF ANY OF THESE ISSUES TILL NOW. ALSO NOTED WAS AN IMPEDANCE ISSUE AT CONTACT 8/RIGHT LEAD. THE CONTACT IS NOT BEING USED. UNKNOWN IF THE ISSUE IS RESOLVED. THE SURGEON DID REPLACE THE INS WITH A NEW ONE. CONTACT 8 HAD AN OPEN ON THE RIGHT LEAD. PRE CHANGE IT WAS 20K OHMS IMPEDANCES. AFTER THE BATTERY CHANGE IT INCREASED TO 37K. THE DOCTOR DID NOT WANT TO TROUBLESHOOT IT AT THE TIME AS OVER TIME THEY WILL SEE IF THE PATIENT'S INFECTION WAS NOT BETTER AND THEY WILL NEED THE COMPLETE STAGE EXPLANT. THE PATIENT HAS A FALL RIGHT AFTER INITIAL IMPLANT OF ABOUT 2 YEARS AGO. THE PATIENT FAILED TO REPORT SHE FELL AND HIT HER HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165108 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention