BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2250158 · Received September 15, 2011

    Report

    Report Number
    3006630150-2011-01457
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    April 14, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PHYSICIAN REVISED THE PATIENT'S POCKET DUE TO PAIN AND MOVED IT TO A DIFFERENT LOCATION. THE PATIENT IS REPORTEDLY DOING WELL. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A POCKET REVISION DUE PAIN AT THE IPG SITE. THE PHYSICIAN DETERMINED NON-DEVICE RELATED WEIGHT LOSS IS CAUSING THE IPG TO MOVE AROUND IN THE POCKET AND BUMP INTO SCAR TISSUE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A POCKET REVISION DUE PAIN AT THE IPG SITE. THE PHYSICIAN DETERMINED NON-DEVICE RELATED WEIGHT LOSS IS CAUSING THE IPG TO MOVE AROUND IN THE POCKET AND BUMP INTO SCAR TISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention