BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3171174 · Received June 14, 2013

    Report

    Report Number
    3006630150-2013-01233
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ALSO EXPERIENCING DRAINAGE AT THE IPG SITE. INFECTION HAD IMPROVED SIGNIFICANTLY BUT WAS NOT CONFIRMED IF IT HAD CLEARED UP. THE PHYSICIAN BELIEVED THAT INFECTION WAS PROCEDURE RELATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S INCISION SITE WAS HEALED UP. THE PATIENT WAS DOING WELL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-50, SERIAL / LOT #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD INFECTION AT THE POCKET SITE. SYMPTOMS INCLUDE SWELLING AND REDNESS. THE PATIENT WAS GIVEN ANTIBIOTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD INFECTION AT THE POCKET SITE. SYMPTOMS INCLUDE SWELLING AND REDNESS. THE PATIENT WAS GIVEN ANTIBIOTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD INFECTION AT THE POCKET SITE. SYMPTOMS INCLUDE SWELLING AND REDNESS. THE PATIENT WAS GIVEN ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271084 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention