BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3132619 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08291
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 9, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 37744 LOT# SERIAL# (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3708140 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID: 3708140 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT ON (B)(6) 2012 THE PATIENT HAD TO CALL 911 AND WAS TAKEN TO THE HOSPITAL AS HE WAS BLEEDING, WITH SYMPTOMS OF AN INFECTION, PAIN, LOSS OF WEIGHT AND APPETITE. ATTORNEY ALLEGES THAT AT THE HOSPITAL IT WAS ALLEGEDLY IDENTIFIED THAT THE PATIENT WAS WITH SEPSIS AND INFECTION FROM THE IMPLANT OF THE IMPLANTABLE NEUROSTIMULATOR AND THE PATIENT HAD ANOTHER SURGERY TO CLEAN THE WOUND FROM THE FIRST SURGERY, DRAIN AND EVALUATE THE INFECTION. ATTORNEY ALLEGES THAT FROM THE STUDIES REALIZED, IT WAS IDENTIFIED THAT THE IMPLANTABLE NEUROSTIMULATOR WAS INFECTED AND IT WAS REMOVED DURING A THIRD SURGERY. ATTORNEY ALLEGES THAT THE CAUSE OF THE INCIDENT WAS BY NOT PROPERLY DEALING WITH THE TRANSPORT, USE, AND IMPLANT OF THE DEVICE. INFORMATION WAS ALSO REPORTED IN MANUFACTURER'S REPORT # 3007566237-2013-01966. ADDITIONAL INFORMATION WILL BE REPORTED IN MANUFACTURER'S REPORT # 3004209178-2013-08291.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN IMPLANTABLE NEUROSTIMULATOR (INS) ON 2012 (B)(6). ON 2012 (B)(6), THE PATIENT CALLED 911 AND WAS TAKEN TO THE HOSPITAL WITH BLEEDING AND HAD SYMPTOMS OF INFECTION, PAIN, WEIGHT LOSS, AND LOSS OF APPETITE. AT THE HOSPITAL, IT WAS FOUND THAT THE PATIENT HAD SEPSIS AND INFECTION FROM THE IMPLANT OF THE INS. THE PATIENT UNDERWENT SURGERY TO CLEAN THE WOUND AND DRAIN AND EVALUATE THE INFECTION. IT WAS STATED THAT THE INS WAS INFECTED AND IT WAS REMOVED IN A THIRD SURGERY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237053 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R