BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2870390 · Received December 12, 2012

    Report

    Report Number
    3006630150-2012-02292
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION. DURING THE PROCEDURE, THE IPG DID NOT CHARGE SO THE PHYSICIAN REPLACED IT WITH A NEW ONE. THE LEADS WERE ALSO REPLACED PER THE PHYSICIAN'S PREFERENCE. THE PATIENT WAS DOING FINE FOLLOWING THE PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS DISCOMFORT AT THE POCKET SITE. THE PATIENT IS SCHEDULED FOR A REVISION TO MOVE THE IPG TO ANOTHER SITE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS DISCOMFORT AT THE POCKET SITE. THE PATIENT IS SCHEDULED FOR A REVISION TO MOVE THE IPG TO ANOTHER SITE.

    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 64 YR Required Intervention