BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3072832 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06745
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 11, 2013
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3550-39, LOT # N236308, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNSATISFIED WITH THEIR ANALGESIA AND THEIR LEAD HAD MIGRATED. THE MIGRATION WAS CONFIRMED BY FLUOROSCOPIC IMAGING OF THE PATIENT'S SYSTEM ON (B)(6) 2013. IT WAS ALSO REPORTED THE PATIENT HAD LOW BACK PAIN AND LOWER EXTREMITY PAIN "GREATER IN THE LEFT THAN RIGHT." IT WAS NOTED THE PATIENT ALSO HAD RECENT CHANGES IN THEIR STIMULATION PATTERN AND NO INTERVENTIONS HAD BEEN TAKEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE ETIOLOGY OF THE EVENT WAS RELATED TO THE DEVICE THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE LEADS WERE SURGICALLY REVISED ON (B)(6) 2013. AS OF THE DAY OF THIS REPORT, THE PATIENT OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173727 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention