BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE SPINAL FUSION STIMULATOR

    MDR report key: 2261672 · Received September 23, 2011

    Report

    Report Number
    2242816-2011-00114
    Event Type
    Injury
    Date Received
    September 23, 2011
    Date of Event
    August 25, 2011
    Report Date
    August 30, 2011
    Manufacturer
    EBI, LLC
    Product Code
    LOE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE INDICATE THAT IN RANDOMIZED AND NON-RANDOMIZED CLINICAL STUDIES INVOLVING 493 PATIENTS USING THE MODEL SPF-4, TWENTY-TWO ADVERSE EVENTS (4%) WERE REPORTED; OF WHICH 5 WERE FOR REPORTED INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN THAT THE PATIENT EXPERIENCED A WOUND INFECTION AT THE SUBCUTANEOUS TISSUE WHERE THE BATTERY WAS PLACED. THE BATTERY WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE SPINAL FUSION STIMULATOR STIMULATOR, 10-1335M LOE EBI, LLC 218106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other