BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4173593 · Received October 15, 2014

    Report

    Report Number
    3004209178-2014-19724
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    September 29, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS STIMULATION IN THE WRONG LOCATION AND THE LOCATION WAS IN THE LEFT LOW BACK AND UPPER LEFT LEG. THE PATIENT REPORTED NO STIMULATION IN LOW BACK SINCE IMPLANT AND EXPERIENCED LESS THAN 50% THERAPY. A PREVIOUS REPROGRAMMING ATTEMPT WAS UNSUCCESSFUL, SO AN X-RAY WAS TAKEN WHICH SHOWED A CEPHALAD MIGRATION OF LEFT LEAD WHILE THE RIGHT LEAD APPEARED UNCHANGED. THE PATIENT DENIED A FALL OR NEAR FALL. REPROGRAMMING WAS ATTEMPTED WITH CURRENT X-RAY AND STIMULATION WAS UNABLE TO BE OBTAINED IN THE PATIENT'S LOW BACK. A LEAD REVISION WAS PLANNED, BUT NOT YET SCHEDULED. FINAL OUTCOME WAS NOT REPORTED. FOLLOW UP INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PLAN WAS TO ADJUST THE POSITION OF THE LEAD, NOT REMOVE OR REPLACE IT. THE PATIENT HAD A LEAD REVISION ON (B)(6) 2014 WITH EFFECTIVE PAIN RELIEF IMMEDIATELY POST-OP. THE MANUFACTURER REPRESENTATIVE (REP) HAD NOT HAD CONTACT WITH THE PATIENT SINCE THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654767 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention