BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2003837 · Received February 24, 2011

    Report

    Report Number
    3006630150-2011-00272
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT HAD A POCKET REVISION. NOTHING WAS IMPLANTED OR EXPLANTED AND THE PATIENT IS REPORTEDLY DOING WELL. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE IPG 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 PAIN AT THE IPG SITE. THE PHYSICIAN ASSESSED THE PATIENT AND SUGGESTED THE PATIENT UNDERGO A POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WAS EXPERIENCING PAIN AT THE IPG SITE. THE PHYSICIAN ASSESSED THE PT AND SUGGESTED THE PATIENT UNDERGO 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 UNK Required Intervention