BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPF-PLUS 60/M (MINI)

    MDR report key: 2448346 · Received February 13, 2012

    Report

    Report Number
    0002242816-2012-00011
    Event Type
    Injury
    Date Received
    February 13, 2012
    Date of Event
    January 14, 2012
    Report Date
    January 15, 2012
    Manufacturer
    EBI, LLC
    Product Code
    LOE
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN'S MANUAL/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 THAT A REVISION SURGERY WAS CONDUCTED TO REMOVE THE IMPLANTABLE STIMULATOR AS THE PATIENT HAD CONTRACTED AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPF-PLUS 60/M (MINI) SPF-PLUS 60/M (MINI) LOE EBI, LLC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R