BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 7984834 · Received October 19, 2018

    Report

    Report Number
    3004209178-2018-23453
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    October 12, 2018
    Report Date
    October 29, 2018
    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
    TN, US
    Reporter Occupation
    003

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT AN X-RAY WAS TAKEN AND THE PATIENT¿S PNS LEADS APPEARED TO BE IN THE SAME PLACE AS IMPLANTED. THE REP REPORTED THAT THE CAUSE OF THE HIGH IMPEDANCES WASN¿T DETERMINED AND NO ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE THE ISSUE. THE CAUSE OF THE OUT OF REGULATION (OOR)/INABILITY TO INCREASE STIMULATION WASN¿T DETERMINED BUT THE REP WAS TOLD BY TECH SERVICES THAT IT WAS SECONDARY TO LIMITATIONS OF OUTPUT BY THE NEUROSTIMULATOR (INS). NO ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE THE OOR/INABILITY TO INCREASE STIMULATION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE, REGARDING PATIENT'S NEUROSTIMULATOR (INS) THAT WAS IMPLANTED FOR MULTIPLE BACK OPERATIONS AND SPINAL PAIN. CALLER REPORTED HE CAN'T INCREASE THERAPY TO A LEVEL THAT THE PATIENT WANTS IT TO BE AT. THE CALLER STATED THAT HE MET WITH THE PATIENT LAST WEEK ON (B)(6) 2018 AND THEY PROGRAMMED THE PATIENT AND WERE ABLE TO GET THE INTENSITY TO A LEVEL THAT WAS COMFORTABLE FOR THE PATIENT. PATIENT DID NOT USE THERAPY FOR 2 DAYS. THEN ON THE (B)(6) TURNED STIM BACK ON AND WAS NOT ABLE TO INCREASE IT HIGH ENOUGH. THE PATIENT COULD FEEL STIM SENSATION BUT WASN'T FEELING IT STRONG ENOUGH. THE REP IS WITH THE PATIENT AND THEY ARE ATTEMPTING TO PROGRAM THE INS. THE CALLER STATED THAT HE TRIED AT LEAST 30 ELECTRODE COMBINATIONS WITH DIFFERENT RATES AND PULSE WIDTHS BUT WHEN THEY INCREASE STIM THE PATIENT FEELS STIM BUT THE DEVICE REACHES OOR BEFORE THEY GET THE THERAPY THAT THE PATIENT WANTS. THE CALLER PROVIDED THE FOLLOWING IMPEDANCES FROM THE TABLET: REF 0 7 40000 13 40000 RANGE OF 1 730 OHMS TO 6 940OHMS FOR ALL OTHERS REF 1 RANGE OF 710 - 890OHMS 7 AND 13 AT 40000OHMS CALLER WAS ASKED TO PROGRAM 0+ 1- 450US 60HZ THE PATIENT IS FEELING STIMULATION AT 5MA BUT GETTING OOR AT 11.4MA AND IT ISN'T STRONG ENOUGH. THE CALLER COULD NOT ACCESS THE REPORT FROM THE SESSION ON 10 OCT 2017 TO COMPARE PREVIOUS IMPEDANCE VALUES. THE CALLER WILL REVIEW INFORMATION WITH THE MD AND MAY GET AN X-RAY. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823744 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR