BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2170614 · Received July 21, 2011

    Report

    Report Number
    3006630150-2011-01113
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG PASSED VISUAL, PHOTOGRAPHIC IMAGING AND PERFORMANCE TESTS. DEVICE EXHIBITS NORMAL CHARGING AND DISCHARGING CHARACTERISTICS. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED LEAD REVEALED NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE REPORTED EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE IPG REPLACEMENT SURGERY THE PHYSICIAN ALSO EXPLANTED A LEAD DUE TO HIGH IMPEDANCE READINGS. THE PATIENT IS DOING WELL FOLLOWING THE REVISION. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#:SC-2138-50, (B)(4) & (B)(4), DESCRIPTION:SCS 50CM III LEAD THE EXPLANTED LEAD WILL NOT BE RETURNED TO BSN FOR FURTHER EVALUATION AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS HAVING TROUBLE CHARGING THEIR IMPLANT. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS HAVING TROUBLE CHARGING THEIR IMPLANT. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS HAVING TROUBLE CHARGING THEIR IMPLANT. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    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 59 YR Required Intervention