BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3831600 · Received May 26, 2014

    Report

    Report Number
    3006630150-2014-01174
    Event Type
    Injury
    Date Received
    May 26, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-4316, LOT #: 16637197, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE, THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A STABBING PAIN AT THE LEAD INCISION SITE. THE PHYSICIAN BELIEVED THAT THE PAIN WAS FROM THE PERMANENT IMPLANT PROCEDURE WHERE LAMINECTOMY WAS PERFORMED. THE PATIENT WAS PRESCRIBED PAIN MEDICATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A STABBING PAIN AT THE LEAD INCISION SITE. THE PHYSICIAN BELIEVED THAT THE PAIN WAS FROM THE PERMANENT IMPLANT PROCEDURE WHERE LAMINECTOMY WAS PERFORMED. THE PATIENT WAS PRESCRIBED PAIN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309883 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention