BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2161931 · Received July 14, 2011

    Report

    Report Number
    3006630150-2011-01028
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A GOOD FAITH EFFORT WAS MADE TO FOLLOW UP WITH THE PATIENT, REGARDING THE USE OF THE LIDODERM PATCHES, BUT WAS UNSUCCESSFUL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE IPG SITE WHILE SHE WAS CHARGING. THE PHYSICIAN PRESCRIBED LIDODERM PATCHES FOR THE PATIENT TO PLACE OVER THE IPG SITE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE IPG SITE WHILE SHE WAS CHARGING. THE PHYSICIAN PRESCRIBED LIDODERM PATCHES FOR THE PATIENT TO PLACE OVER THE IPG SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention