BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2880473 · Received December 19, 2012

    Report

    Report Number
    3006630150-2012-02350
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-2218-50, SERIAL: (B)(4), DESCRIPTION:LINEAR 3-4 LEAD, 50CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER ACTION WILL BE TAKEN SINCE WE HAVE NOT HEARD FROM THE PATIENT OR FROM THE PHYSICIAN'S OFFICE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION OF THE INCISION AT THE LEAD SITE AFTER REIMPLANTATION. SYMPTOM WAS REDNESS AT THE INCISION SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS PROCEDURE RELATED. ANTIBIOTICS WERE GIVEN TO THE PATIENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION OF THE INCISION AT THE LEAD SITE AFTER REIMPLANTATION. SYMPTOM WAS REDNESS AT THE INCISION SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS PROCEDURE RELATED. ANTIBIOTICS WERE GIVEN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention