BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 7711646 · Received July 23, 2018

    Report

    Report Number
    3007566237-2018-02187
    Event Type
    Injury
    Date Received
    July 23, 2018
    Date of Event
    July 19, 2018
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    00613994925961
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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 HCP VIA A MANUFACTURER REPRESENTATIVE REPORTING THAT THE CAUSE WAS SUSPECTED TO BE RELATED TO ANESTHESIA. THE PATIENT WAS STILL NOT ABLE TO VOID. THE LEAD PULL WAS PLANNED TO BE ON (B)(6) 2018. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WITH A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS) FOR AND UNKNOWN INDICATION FOR USE. IT WAS REPORTED THAT ON (B)(6) 2018 IN POST-OP, THE PATIENT WAS UNABLE TO OBTAIN PARASTHESIA DUE TO THE OOR (OUT OF REGULATION) MESSAGE. THE PATIENT WAS UNABLE TO USE THEIR PATIENT PROGRAMMER TO ADJUST STIMULATION TO THE DESIRED SETTINGS BECAUSE OF THE OOR. THE THERAPY WAS UNABLE TO BE DELIVERED WITH PARASTHESIA. THE THERAPY WAS CURRENTLY BEING DELIVERED WITHOUT PARASTHESIA AS THE SYSTEM CANNOT PROVIDE ENOUGH OUTPUT FOR PARASTHESIA. NO FACTORS WERE REPORTED THAT MAY HAVE CONTRIBUTED TO THE ISSUE. THE REP INDICATED THAT THEY DID TRY VARYING RATES, PULSE WIDTHS (PWS) AND ELECTRODE CONFIGURATIONS WITH THE SAME RESULTS. THE IMPEDANCES WERE ALL WITHIN RANCE AND A PICTURE SHOWING THIS WAS SENT. IT WAS REPORTED THAT THE PATIENT LEFT WITH A SIMPLE BI POLE ON 6 THROUGH 7 WITH THE PW220 AND THE RATE AT 1000 PER USE OF SPECIAL DENSITY PROGRAMMING PROTOCOL. THE REP INDICATED THAT THEY WOULD EVALUATE FOR PAIN RELIEF. IF THERE ARE NO RESULTS THEY WOULD BRING THE PATIENT BACK IN FOR REPROGRAMMING AND AGAIN ATTEMPT TO DELIVER PARASTHESIA. THE ISSUE HAD NOT BEEN RESOLVED AT THE TIME OF THE REPORT. NO SURGICAL INTERVENTION HAS BEEN PERFORMED OR PLANNED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. THEY WERE INFORMED THAT THE PATIENT HAD NOT BEEN ABLE TO VOID SINCE THE TRIAL PROCEDURE ON (B)(6) 2018, AND AS A RESULT THE PATIENT HAD TO SELF CATHETERIZE 4 TIMES. THE REP REDIRECTED THE PATIENT TO THEIR DOCTOR AND TO SHUT OFF THE STIMULATION TO DETERMINE IF THE STIMULATION WAS CONTRIBUTING TO THE INABILITY TO VOID. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552127 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 97725 00613994925961

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR