BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 5237185 · Received November 19, 2015

    Report

    Report Number
    3004209178-2015-23122
    Event Type
    Injury
    Date Received
    November 19, 2015
    Report Date
    October 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3998 LOT# V060415, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3998, LOT# V057371, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL (HCP) REPORTED AN ALLERGIC REACTION. THE ALLERGY WAS NOT CONFIRMED. THE HCP STATED THEY WERE IN THE PROCESS OF DETERMINING IF POSSIBLE ALLERGIC REACTION DUE TO DEVICE, SUTURES, MEDICAL TAPE. TESTING BEGINS FOR CONTACT PATCH TESTING ON (B)(6) 2015. THE SITUATION WAS BEING ADDRESSED BY THE HCP. SYMPTOMS REPORTED WERE ERYTHEMA, POST SURGICAL SWELLING, CUTANEOUS PAIN, POOR WOUND HEALING, ABSCESS, NEGATIVE FOR INFECTION. THE LOCATION OF THE SYMPTOMS WERE AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. ON (B)(6) 2015 THE PATIENT SAW MANAGING PAIN HCP FOR CONTACT DERMATITIS. DERMATOLOGY WAS CURRENTLY FOLLOWING THE PATIENT FOR DERMATOLOGY. MEDICAL HISTORY INCLUDES SPINAL PAIN AND FAILED BACK SURGERY SYNDROME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767027 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention