BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3900533 · Received June 27, 2014

    Report

    Report Number
    3006630150-2014-01429
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPLANTED. THE PHYSICIAN DID NOT BELIEVE THAT THE SWELLING AND ITCHING AROUND THE PATIENT'S FACE WAS DEVICE RELATED. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2352-70, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR 3-4 LEAD, 70CM. MODEL #: SC-3138-25, SERIAL/LOT #: (B)(4), DESCRIPTION: SCS PHIII EXT 25CM. MODEL #: SC-1110-02, SERIAL/LOT #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT FELT TUGGING OF THE LEADS UPON THE IPG AND THE STIMULATION WORSENED THE PATIENT¿S GENERAL PAIN. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT FELT TUGGING OF THE LEADS UPON THE IPG AND THE STIMULATION WORSENED THE PATIENT¿S GENERAL PAIN. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT FELT TUGGING OF THE LEADS UPON THE IPG AND THE STIMULATION WORSENED THE PATIENT¿S GENERAL PAIN. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377578 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention