BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL STIMULATOR

    MDR report key: 4812822 · Received June 2, 2015

    Report

    Report Number
    3007566237-2015-01520
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    April 22, 2015
    Report Date
    May 11, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-30, LOT # 0209356287, IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2015, PRODUCT TYPE LEAD; PRODUCT ID 37081-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2015, PRODUCT TYPE EXTENSION; PRODUCT ID 37081-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2015, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A STAPHYLOCOCCUS AUREUS INFECTION AT THE LOWER ABDOMINAL SCAR THAT WAS RELATED TO THE LEAD AND EXTENSIONS. THE PATIENT HAD AN OOZING WOUND IN THE RIGHT LOWER QUADRANT NOTED AT THE END OF THE SCREENING TEST. EVENT REQUIRED EXPLANT AND PROLONGATION OF HOSPITALIZATION. EVENT WAS RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A FOREIGN CLINICAL STUDY REPORTED THAT THE EXTENSION AND LEAD WAS EXPLANTED DURING TRIALING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTHCARE PROFESSIONAL OF THE FOREIGN CLINICAL STUDY REPORTED THE PATIENT HAD FIBROSIS DUE TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355203 UNKNOWN EXTERNAL STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Hospitalization| R