BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1841522 · Received September 14, 2010

    Report

    Report Number
    3006630150-2010-01579
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING TO CHARGE HER IPG MORE OFTEN. THE PHYSICIAN FELT THE IPG WAS COMPROMISED AND NEEDED TO BE REPLACED. THE IPG WAS REPLACED AND THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention