BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2872186 · Received December 13, 2012

    Report

    Report Number
    3006630150-2012-02303
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    October 23, 2012
    Report Date
    November 27, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT HAVE AN ENLARGED POCKET SITE. THE DIFFICULTIES CHARGING WERE RELATED TO A FATTY LAYER OVER THE IPG AND THE IPG FLIPPING. THE EVENT WAS NOT RELATED TO THE PROCEDURE OR DEVICE.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE REPORTED IN THIS MDR FORM FALLS UNDER INVESTIGATIONAL DEVICE EXEMPTION (IDE) AND SHOULD NOT HAVE BEEN REPORTED ON A 3500A MDR FORM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT IS RELATED TO THE PROCEDURE AND NOT THE DEVICE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED DUE TO CHARGING DIFFICULTIES. IT WAS REPORTED THAT THE PATIENT HAD AN ENLARGED POCKET WHICH CAUSED THE IPG TO TURN. THE PATIENT UNDERWENT A POCKET REVISION AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED DUE TO CHARGING DIFFICULTIES. IT WAS REPORTED THAT THE PATIENT HAD AN ENLARGED POCKET WHICH CAUSED THE IPG TO TURN. THE PATIENT UNDERWENT A POCKET REVISION AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED DUE TO CHARGING DIFFICULTIES. IT WAS REPORTED THAT THE PATIENT HAD AN ENLARGED POCKET WHICH CAUSED THE IPG TO TURN. THE PATIENT UNDERWENT A POCKET REVISION AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED DUE TO CHARGING DIFFICULTIES. IT WAS REPORTED THAT THE PATIENT HAD AN ENLARGED POCKET WHICH CAUSED THE IPG TO TURN. THE PATIENT UNDERWENT A POCKET REVISION AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION DB-1110-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R