BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2071047 · Received April 27, 2011

    Report

    Report Number
    3006630150-2011-00562
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE DEVICE FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN, SORENESS AND WARMTH AT THE IPG SITE. THE PHYSICIAN ASSESSED THE IPG SITE TWO WEEKS AGO AND SAID THAT EVERYTHING LOOKED LIKE IT WAS HEALING FINE AND THERE WAS NO INFECTION. THE PATIENT HAD SOME BONE TAKEN OUT OF HER ILIAC CREST DURING ANOTHER PROCEDURE A YEAR AGO (NOT DEVICE RELATED). THE PHYSICIAN BELIEVES THE IMPLANT PROCEDURE MAY HAVE AFFECTED THE OLD PROCEDURE SITE AND PRESCRIBED LIDOCAINE TO THE PATIENT. THE PATIENT IS REPORTEDLY DOING FINE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN, SORENESS AND WARMTH AT THE IPG SITE. THE PHYSICIAN ASSESSED THE IPG SITE TWO WEEKS AGO AND SAID THAT EVERYTHING LOOKED LIKE IT WAS HEALING FINE AND THERE WAS NO INFECTION. THE PATIENT HAD SOME BONE TAKEN OUT OF HER ILIAC CREST DURING ANOTHER PROCEDURE A YEAR AGO (NOT DEVICE RELATED). THE PHYSICIAN BELIEVES THE IMPLANT PROCEDURE MAY HAVE AFFECTED THE OLD PROCEDURE SITE AND PRESCRIBED LIDOCAINE TO THE PATIENT. THE PATIENT IS REPORTEDLY DOING FINE.

    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 Required Intervention