BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4063441 · Received September 5, 2014

    Report

    Report Number
    3004209178-2014-16438
    Event Type
    Injury
    Date Received
    September 5, 2014
    Report Date
    October 3, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3487A-33, LOT # J0236935V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 3487A-33, LOT # J0236935V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708360, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3708360, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-33, LOT # J0236935V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 3487A-33, LOT # J0236935V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S SYSTEM WAS REPLACED, LEADS AND BATTERY, ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT WAS RECEIVING EXCELLENT THERAPY NOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿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¿CALL YOUR DOCTOR¿ ICON WAS SEEN WITH EOS FOR OVER A MONTH AND THE PATIENT HAD NO STIMULATION DURING THAT TIME. THE PATIENT NOTED THAT HE F ELT HE WAS ¿GETTING THE RUNAROUND¿ TRYING TO GET AN APPOINTMENT. IT WAS NOTED THAT THE PATIENT HAD HIGH POWER REQUIREMENTS AND NEEDED A RECHARGEABLE BATTERY. IT WAS NOTED THAT THE DEVICE WOULD BE EVALUATED. IT WAS FURTHER REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE REVIEWED THE PATIENT¿S SYSTEM AND ONE OF HIS LEADS HAD MULTIPLE FRACTURED ELECTRODES WHICH CAUSED AN ¿EXCESSIVE DRAIN¿ ON THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS STATED THAT THE PATIENT WAS REFERRED TO AN HCP FOR COMPLETE REVISION/ REPLACEMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS BEING SEEN NEXT WEEK AND WOULD BE SCHEDULED FOR REPLACEMENT SOON AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546286 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention