BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR, UNKNOWN

    MDR report key: 3910332 · Received July 2, 2014

    Report

    Report Number
    3007566237-2014-01854
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 11, 2014
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-30, LOT# 0208297800, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 39565-30, LOT# 0208297800, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 37081-60, SERIAL# (B)(4), EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 37081-60, SERIAL# (B)(4), EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 37081-60, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-30, LOT# 0208297800, PRODUCT TYPE: LEAD; PRODUCT ID 39565-30, LOT# 0208297800, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-30; LOT # 0208297800, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 39565-30; LOT # 0208297800, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 37081-60; SERIAL # (B)(4), EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION. IT WAS NOTED THAT THE WOUND CULTURE RESULTS SHOWED INFECTION. IT WAS NOTED THAT SIGNS AND SYMPTOMS INCLUDED PROGRESSIVE PAIN NEAR THE VERTEBRAL COLUMN. IT WAS NOTED THAT THERE WAS SANIOUS PUS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE. IT WAS NOTED THAT INTERVENTIONS INCLUDED A MEDICATION ADJUSTMENT FOR ¿ANTIBI.¿ IT WAS NOTED THAT THE WOUND CULTURE RESULTS SHOWED STAPHYLOCOCCUS AUREUS INFECTION. IT WAS NOTED THAT THE EVENT WAS RELATED TO THE DEVICE OR THERAPY AND RELATED TO THE PROCEDURE. IT WAS NOTED THAT THERE WAS ¿EXTERNALIZATION OF THE EXTENSION CABLES FOR ONE MONTH.¿ IT WAS NOTED THERE WAS WOUND EXUDATE AT THE HEIGHT OF THE SPINE WOUND. IT WAS NOTED THAT THERE WAS REDNESS AND SWELLING NEAR THE SPINE WOUND. IT WAS NOTED THAT THERE WAS IN-PATIENT OR PROLONGED HOSPITALIZATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANT. IT WAS NOTED THAT IT WAS ONLY SPINAL CORD STIMULATION (SCS) TRAILING SYSTEM. IT WAS NOTED THAT THE INFECTION WAS RELATED TO THE LEAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE EVENT RESULTED IN IN-PATIENT OR PROLONGED HOSPITALIZATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE EVENT WAS RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS AN INFECTION AT THE EXTENSION CABLE AT THE BACK SIDE. IT WAS NOTED THAT INTERVENTIONS INCLUDED ANTIBIOTICS INTRAVENOUSLY ON (B)(6) 2014. IT WAS NOTED THAT THE EVENT WAS RELATED TO THE DEVICE OR THERAPY AND LEAD 1. IT WAS NOTED THAT THERE WAS EXTERNALIZATION FOR ONE MONTH OF THE EXTENSION CABLES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE OUTCOME WAS AN ONGOING EVENT. IT WAS NOTED THAT INTERVENTION INCLUDED MEDICATION ADJUSTMENT. IT WAS NOTED THAT INTERVENTIONS INCLUDED DEVICE EXPLANT ON (B)(6) 2014. IT WAS NOTED THAT THE LEAD AND EXTENSION WERE EXPLANTED. IT WAS NOTED THAT THE EVENT WAS RELATED TO THE DEVICE OR THERAPY AND RELATED TO THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386917 EXTERNAL NEUROSTIMULATOR, UNKNOWN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R