BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 7717018 · Received July 24, 2018

    Report

    Report Number
    3006630150-2018-60340
    Event Type
    Injury
    Date Received
    July 24, 2018
    Date of Event
    June 27, 2018
    Report Date
    July 24, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789567
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2366-70; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 50239325/5024106/5024407 ; MODEL/CATALOG DESCRIPTION: LINEAR 3-6 LEAD 70 CM. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS 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 WAS ADMITTED TO THE HOSPITAL DUE TO SKIN BREAKAGE AS ONE OF THE PERIPHERAL LEADS WAS STICKING OUT OF THE SKIN. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555739 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 5023754 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R