BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3840568 · Received May 30, 2014

    Report

    Report Number
    3006630150-2014-01169
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    January 15, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT RESOLVED.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT¿S STATUS HAS IMPROVED SLIGHTLY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED AN EVENT OF HIATAL HERNIA AND GASTRO ESOPHAGEAL REFLUX. THE PHYSICIAN ASSESSED THAT THE PATIENT¿S SYMPTOMS WERE DEVICE RELATED. THE PATIENT WAS REPROGRAMMED AND PROVIDED A GASTRIC PROTECTOR. THE EVENT HAS NOT RESOLVED AND THE PATIENT HAS NOT RECOVERED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED AN EVENT OF HIATAL HERNIA AND GASTRO ESOPHAGEAL REFLUX. THE PHYSICIAN ASSESSED THAT THE PATIENT¿S SYMPTOMS WERE DEVICE RELATED. THE PATIENT WAS REPROGRAMMED AND PROVIDED A GASTRIC PROTECTOR. THE EVENT HAS NOT RESOLVED AND THE PATIENT HAS NOT RECOVERED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED AN EVENT OF HIATAL HERNIA AND GASTRO ESOPHAGEAL REFLUX. THE PHYSICIAN ASSESSED THAT THE PATIENT¿S SYMPTOMS WERE DEVICE RELATED. THE PATIENT WAS REPROGRAMMED AND PROVIDED A GASTRIC PROTECTOR. THE EVENT HAS NOT RESOLVED AND THE PATIENT HAS NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319527 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention