BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3955832 · Received July 24, 2014

    Report

    Report Number
    3004209178-2014-13493
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 977A290, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 977A290, SERIAL# (B)(4) IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 977A290, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 977A290, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); 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

    ADDITIONAL INFORMATION THAT THERE WAS NO UPDATE ON THE PATIENT'S STATUS. IT WAS REPORTED THAT THE CASE WAS SCHEDULED FOR (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED REPORTED THAT A DIFFERENT MANUFACTURER'S REPRESENTATIVE HAD BEEN PRESENT AT THE REVISION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD HIS 2 OCTAD LEADS REPLACED BY 4 QUAD PLUS LEADS ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE STIMULATION AT THIS POINT.

    Description of Event or Problem · 1

    CORRECTIVE MDR SUBMITTED TO SYSTEM REPORT THE LEADS (PLI 10 AND PLI 20) DUE TO THE ISSUE BEING RESOLVED BY THE LEAD REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD STIMULATION IN THE WRONG LOCATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AND WANTED THE STIMULATION LOWER. REPROGRAMMING WAS ATTEMPTED BUT THIS DID NOT WORK. ADDITIONAL DIAGNOSTICS/TROUBLESHOOTING INVOLVED IMPEDANCE TESTING (RESULTS NOT SPECIFIED). THERE WERE NO REPORTED PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. A REVISION WAS TO BE SCHEDULED TO REMOVE THE CURRENT LEADS AND PLACE ¿4 WIDE SPACE QUADS¿ LEADS WITH 2 EXTENSION COMPONENTS. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS NOTED AS ¿ALIVE NO INJURY¿. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434184 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention