BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 5191042 · Received October 30, 2015

    Report

    Report Number
    3004209178-2015-21873
    Event Type
    Injury
    Date Received
    October 30, 2015
    Report Date
    March 28, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 97792, LOT# N540074, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED NEUROSTIMULATOR MODEL 97714, SERIAL #(B)(4), SHOWED NO SIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER (HCP) REPORTED THE PATIENT COMPLAINED OF HEATING AT THE POCKET SITE. THE PATIENT CLAIMED THE DEVICE WAS HEATING UP INTERNALLY AT THE POCKET SITE WHEN USING IT. THE PATIENT EXPERIENCED THIS SENSATION AFTER THE DEVICE WAS ON FOR 15 MINUTES, AND WOULD THEN FEEL LIKE HE NEEDED TO TURN IT OFF BECAUSE OF THE HEAT. THE PATIENT DIDN'T HAVE STIMULATION ON DURING CHARGING, AND DIDN'T HAVE A PROBLEM WITH HEATING AT THAT TIME. IT WAS NOTED THE IMPLANT WAS WORKING FOR STIMULATION COVERAGE. THERE WERE NO TRAUMAS OR FALLS REPORTED. IMPEDANCE TESTING WAS PERFORMED WITH RESULTS OF 613-1226 OHMS. THE AMPLITUDE WAS REDUCED AND THERAPY IMPEDANCE TESTING WAS PERFORMED WITH RESULTS OF 412 OHMS AND 387 OHMS. A NEW GROUP WAS CREATED WITH BIPOLE OF 3+, 4-, PULSE WIDTH 450, RATE 60 HERTZ, AND 3.5 VOLTS AND THE BATTERY HEATED UP AND THE PATIENT'S SKIN WAS HOT TO THE TOUCH WITHIN ONE MINUTE. THE PATIENT STATED THIS WAS TYPICAL, AND THE BATTERY WOULD CONTINUE TO GET WARMER UNTIL HE HAD TO SHUT IT OFF. THE MANUFACTURER'S REPRESENTATIVE (REP) MET WITH THE PATIENT AND PULLED A MANUFACTURER FILE REGARDING INFORMATION ABOUT THE BATTERY HEATING. RELEVANT MEDICAL HISTORY INCLUDES SPINAL PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE MANUFACTURING REPRESENTATIVE REPORTED THEY USED AN EXOGEN THERMOMETER AND FOUND THAT THERE WAS NO HEATING AT THE SITE OR ANYWHERE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) EXPLANTED. THERE WAS NO OTHER TESTING DONE AS THE PATIENT LET THEIR BATTERY COMPLETELY DIE. IT WAS NOTED THAT THERE WAS NO HEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721431 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention