BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2924261 · Received January 22, 2013

    Report

    Report Number
    3006630150-2013-00098
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2352-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR 3-4 LEAD, 50CM. MODEL #: SC-4316, LOT #: 15598655, DESCRIPTION: CLIK ANCHOR. IT IS INDICATED THAT THE DEVICES 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

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL TEST PERFORMED. THERE WAS NO REPORT OF IPG MALFUNCTION IN THE REPORTED COMPLAINT. (B)(4) DEVICE EVALUATION INDICATED THAT THE LEAD BODY WAS CUT AND ONLY PROXIMAL END PORTION WAS RETURNED. DAMAGE TO THE LEADS IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. A REVIEW OF THE STERILE RECORDS OF THE IPG AND LEADS FOUND NO MANUFACTURING DEFECT AS THE SOURCE OF THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION AT THE LEAD SITE. THE SYMPTOMS INCLUDE LOW GRADE FEVER, CHILLS, REDNESS AND DRAINAGE AT THE SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS PROCEDURE RELATED. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS. THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION AT THE LEAD SITE. THE SYMPTOMS INCLUDE LOW GRADE FEVER, CHILLS, REDNESS AND DRAINAGE AT THE SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS PROCEDURE RELATED. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31242 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention