BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 5707928 · Received June 8, 2016

    Report

    Report Number
    3006630150-2016-01467
    Event Type
    Injury
    Date Received
    June 8, 2016
    Report Date
    May 12, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 #: 112784, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PHYSICIAN DID NOT SUSPECT DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    CORRECTION TO F/U #3 SHOULD HAVE BEEN CHECKED NO, 02 DEVICE EVALUATION ANTICIPATED, BUT NOT BEGUN. THE RETURNED DEVICES WERE ANALYZED AND THE COMPLAINT COULD NOT BE CONFIRMED. SC-2352-50/(B)(4): THE LEAD WAS CUT. DAMAGE TO THE DEVICE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. SC-1110-02 SN (B)(4), SC-4316 LOT 16114076: NO ANOMALIES WERE FOUND. SC-2352-50/(B)(4): A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER COURSE OF ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    MODEL#: SC-4316, LOT #: 16114076, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AND THAT THE VIBRATORY STIMULATION WAS CAUSING SEVERE WORSENING OF MIGRAINE HEADACHES. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AND THAT THE VIBRATORY STIMULATION WAS CAUSING SEVERE WORSENING OF MIGRAINE HEADACHES. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AND THAT THE VIBRATORY STIMULATION WAS CAUSING SEVERE WORSENING OF MIGRAINE HEADACHES. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AND THAT THE VIBRATORY STIMULATION WAS CAUSING SEVERE WORSENING OF MIGRAINE HEADACHES. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AND THAT THE VIBRATORY STIMULATION WAS CAUSING SEVERE WORSENING OF MIGRAINE HEADACHES. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361704 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention