BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 5568180 · Received April 11, 2016

    Report

    Report Number
    3006630150-2016-00816
    Event Type
    Injury
    Date Received
    April 11, 2016
    Date of Event
    March 15, 2016
    Report Date
    March 15, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2352-50, LOT # 3000863, 3031447, 1016905, DESCRIPTION: LINEAR 3-4 LEAD, 50CM. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT ANOTHER LEAD WAS REMOVED. THE PATIENT NOW HAS TWO LEADS IMPLANTED AND IS REPORTEDLY DOING WELL POST-OPERATIVELY. MALFUNCTION WAS NOT SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING AN IMPLANT PROCEDURE, THE PATIENT FELT AS THOUGH A STITCH WAS STILL IN HER NECK. THE PHYSICIAN ASSESSED THAT IT WAS THE SUTURE AROUND ONE OF THE LEADS AND HE DECIDED TO CUT THE ELECTRODE, AND REMOVE THE PROTRUDING BIT. THE PATIENT WAS LEFT WITH A CUT LEAD AND NO ELECTRODE. THE REMAINING THREE LEADS WERE LEFT INTACT. THE PHYSICIAN ADMINISTERED AN ANTIBIOTIC CREAM FOR THE WOUND SITE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING AN IMPLANT PROCEDURE, THE PATIENT FELT AS THOUGH A STITCH WAS STILL IN HER NECK. THE PHYSICIAN ASSESSED THAT IT WAS THE SUTURE AROUND ONE OF THE LEADS AND HE DECIDED TO CUT THE ELECTRODE, AND REMOVE THE PROTRUDING BIT. THE PATIENT WAS LEFT WITH A CUT LEAD AND NO ELECTRODE. THE REMAINING THREE LEADS WERE LEFT INTACT. THE PHYSICIAN ADMINISTERED AN ANTIBIOTIC CREAM FOR THE WOUND SITE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING AN IMPLANT PROCEDURE, THE PATIENT FELT AS THOUGH A STITCH WAS STILL IN HER NECK. THE PHYSICIAN ASSESSED THAT IT WAS THE SUTURE AROUND ONE OF THE LEADS AND HE DECIDED TO CUT THE ELECTRODE, AND REMOVE THE PROTRUDING BIT. THE PATIENT WAS LEFT WITH A CUT LEAD AND NO ELECTRODE. THE REMAINING THREE LEADS WERE LEFT INTACT. THE PHYSICIAN ADMINISTERED AN ANTIBIOTIC CREAM FOR THE WOUND SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222610 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention