BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 5452239 · Received February 22, 2016

    Report

    Report Number
    3004209178-2016-03261
    Event Type
    Injury
    Date Received
    February 22, 2016
    Date of Event
    January 1, 2016
    Report Date
    September 13, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 399945, LOT# V884680, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 399945, LOT# V644430, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 399945, LOT# V884680, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 399945, LOT# V644430, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 399945, LOT# V884680, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 399945, LOT# V644430, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT THOUGHT THE CIRCUMSTANCES WHICH LED TO THE SHOCKING AND SUBSEQUENT CHANGE/LOSS OF STIMULATION WERE THE ACTIVITY LEVEL INCREASE WITH MORE BENDING AND MOVEMENT. THE STEPS TAKEN TO RESOLVE THE SHOCKING AND SUBSEQUENT CHANGE/LOSS OF STIMULATION BY THE PATIENT WERE THAT THEY TRIED TO ADJUST STIMULATION AND FOUND THAT "TWO AREA" WAS NOT WORKING. THE REPRESENTATIVE TRIED TO ADJUST IT AND FOUND THE SAME AREA NOT WORKING. SHE TRIED TO ADD 2 PROGRAMS, BUT THAT ENDED UP CAUSING MORE BURNING. THE PATIENT TURNED IT OFF AND WAS WAITING FOR AN APPOINTMENT WHEN IT CAN FIXED. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT VIA A MANUFACTURER REPRESENTATIVE REPORTED THAT THEY HAD EXPERIENCED TWO SHARP ZAPPING SENSATIONS FOLLOWED BY A LOSS OF STIMULATION ON THE RIGHT SIDE. THEY HAD NO COVERAGE OF THEIR LOW BACK ON THEIR LEFT SIDE WHERE IT USED TO BE. NO FALLS OR TRAUMAS WERE REPORTED LEADING TO THE EVENT. THE IMPEDANCES WERE CHECKED. THE PATIENT WAS INDICATED FOR SPINAL PAIN. NO CAUSES OR INTERVENTIONS WERE REPORTED WITH THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THEY HAD THE LEADS REPLACED THAT WERE NOT WORKING RIGHT AND NOTHING WAS DONE WITH THE BATTERY PACK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE ON (B)(6) 2016. THE PATIENT WAS ALSO HAVING IMPEDANCE ISSUES. ELECTRODES 4-7 WERE SHOWING >20,000 OHMS. THE MANUFACTURER REPRESENTATIVE WAS READING FROM THE PROGRESS NOTES DATED AS (B)(6) 2016. ANOTHER MANUFACTURER REPRESENTATIVE WAS NOTIFIED OF THE IMPEDANCE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109626 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention