BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2111965 · Received June 2, 2011

    Report

    Report Number
    3006630150-2011-00819
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 19, 2011
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG PASSED VISUAL AND PHOTOGRAPHIC IMAGING. THE COMPLAINT OF PREMATURE BATTERY DEPLETION HAS BEEN CONFIRMED. THE ANALOG IC (AIC-U1) WAS DAMAGED. THE MONOPOLAR ELECTROCAUTERY PROCEDURES ARE A KNOWN SOURCE OF HIGH-VOLTAGE TRANSIENT SIGNAL THAT CAN DAMAGE THE AIC-U1. CURRENT LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A REVISION THE PATIENT'S IPG IS NOT HOLDING A CHARGE. BSN REPRESENTATIVE ANALYZED THE PATIENT'S DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. AN IPG REPLACEMENT SURGERY HAS BEEN RECOMMENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A REVISION THE PATIENT'S IPG IS NOT HOLDING A CHARGE. BSN REPRESENTATIVE ANALYZED THE PATIENT'S DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. AN IPG REPLACEMENT SURGERY HAS BEEN RECOMMENDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention