BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE STIMULATOR

    MDR report key: 3863656 · Received June 10, 2014

    Report

    Report Number
    3007566237-2014-01583
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    October 16, 2013
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 3587A, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS DYSFUNCTION OF THE LEAD WHICH LEAD TO LOSS OF STIMULATION. THE PATIENT HAD LESS THAN 50% THERAPY RELIEF IN THEIR LOWER LIMB. IT WAS ALSO NOTED THAT HIGH IMPEDANCE WAS OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED AND THE EVENT RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE CAUSE OF THE HIGH IMPEDANCE WAS DETERMINED TO BE ELECTRODE DYSFUNCTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A FOREIGN CLINICAL STUDY REPORTED THAT THE PATIENT HAD A REAPPEARANCE OF PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A FOREIGN CLINICAL STUDY REPORTED THAT THE EVENT DATE WAS CHANGED TO (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337606 UNKNOWN IMPLANTABLE STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention