BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2071046 · Received April 27, 2011

    Report

    Report Number
    3006630150-2011-00552
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS RECEIVING GOOD STIMULATION AND PAIN COVERAGE. THE PHYSICIAN REVISED THE PATIENT'S IPG AND THE PATIENT WAS REPORTEDLY DOING FINE. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE DEVICES FOUND 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 WAS EXPERIENCING POCKET PAIN AND A SHOOTING PAIN ALONG THE LEADS. THE PATIENT HAD REPORTEDLY LOST ABOUT 100 POUNDS (NOT DEVICE RELATED) MAKING THE IPG MORE VISIBLE AND CLOSER TO THE SKIN. THE PHYSICIAN HAS RECOMMENDED A POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING POCKET PAIN AND A SHOOTING PAIN ALONG THE LEADS. THE PATIENT HAD REPORTEDLY LOST ABOUT 100 POUNDS (NOT DEVICE RELATED) MAKING THE IPG MORE VISIBLE AND CLOSER TO THE SKIN. THE PHYSICIAN HAS RECOMMENDED A POCKET REVISION.

    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 42 YR Required Intervention