BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4131415 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18035
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 12, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 977A160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 977A160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR LEADS REVISED ON THE DAY OF THE REPORT. THE DOCTOR PULLED THE LEADS DOWN LOWER AND THE PATIENT HAD EXCELLENT LOW BACK STIMULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD STIMULATION IN THE WRONG LOCATION. THE PATIENT HAD STIMULATION IN THEIR ANTERIOR CHEST AND NOT THEIR LOW BACK. IMPEDANCE TESTING AND REPROGRAMMING WAS DONE. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. FOLLOW UP WITH A MANUFACTURING REPRESENTATIVE INDICATED THE CAUSE OF THE EVENT WAS LIKELY LEAD POSITION. AN X-RAY WAS DONE AND MEASURED IMPEDANCES WERE WITHIN NORMAL LIMITS. THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY AND THEIR HEALTHCARE PROFESSIONAL SCHEDULED A REVISION FOR (B)(6) 2014. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611773 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention