BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1789968 · Received August 6, 2010

    Report

    Report Number
    3006630150-2010-01427
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS EXPERIENCING DIFFICULTY ESTABLISHING COMMUNICATION BETWEEN THE IPG AND THE REMOTE CONTROL (RC). THE BSN FIELD CLINICAL ENGINEER (FCE) INDICATED THAT THE COMMUNICATION COIL WAS MALFUNCTIONING. IPG REPLACEMENT HAS BEEN RECOMMENDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention IPG KIT (WITHOUT PULL-THROUGH TUNNELER)| MODEL#: SC-1110-02, SERIAL#: (B)(4)