BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3791437 · Received May 5, 2014

    Report

    Report Number
    3006630150-2014-00957
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    January 28, 2014
    Report Date
    April 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE WHEREIN THE NEW IPG WAS RELOCATED AND THE DEPTH WAS ADJUSTED. THE PHYSICIAN DID NOT SUSPECT DEVICE MALFUNCTION. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS UNABLE TO CHARGE THE IPG. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD TENDERNESS AT THE POCKET SITE. THE PATIENT ALSO EXPERIENCED HEATING WHILE CHARGING AND WAS UNABLE TO CHARGE THE IPG. THE PATIENT¿S SKIN TURNED RED FROM CHARGING. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267275 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention