BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3759287 · Received April 18, 2014

    Report

    Report Number
    3004209178-2014-07499
    Event Type
    Injury
    Date Received
    April 18, 2014
    Report Date
    March 17, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3986A, LOT# N202582, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, IMPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6)-2014 TO REPOSITION THE LEAD. IT WAS NOTED THAT THE CASE WENT WELL AND THE MANUFACTURING REPRESENTATIVE WOULD FOLLOW UP WITH THE PATIENT POST OP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD ISSUE WAS NOT IDENTIFIED BEFORE THE SURGERY ON (B)(6) 2014. IT WAS NOTED THAT THE PATIENT EXPERIENCED SYMPTOMS OF RIGHT ARM PAIN AND HEADACHES. IT WAS NOTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM AND THEY WERE UNSURE IF THE PAIN WAS RELATED TO THE DEVICE. IT WAS NOTED THAT A CT SCAN WAS PERFORMED BUT THE RESULTS WERE NOT AVAILABLE. IT WAS UNKNOWN WHEN THE PATIENT NOTICED THE SYMPTOMS. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE DID NOT KNOW WHAT THE DEVICE WAS IMPLANTED FOR, BUT SHE BELIEVED IT WAS FOR RIGHT SIDED PAIN. IT WAS NOTED THAT THE LEAD ISSUE WAS IDENTIFIED DURING THE REVISION. IT WAS UNKNOWN IF THE PATIENT'S THERAPY WAS EFFECTIVE AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S LEAD WAS NOT PLACED IN THE PROPER AREA AND NEEDED TO BE REVISED. IT WAS NOTED THAT THE SURGEON RE POSITIONED THE LEAD. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IMPEDANCES OF GREATER THAN 4,000 OHMS WERE SEEN INITIALLY. IT WAS NOTED THAT THERE WERE SOME OUT OF RANGE IMPEDANCES DURING THE REVISION. IT WAS NOTED THAT THE IMPEDANCES RESOLVED. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237950 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention