BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA®

    MDR report key: 6190463 · Received December 20, 2016

    Report

    Report Number
    3006630150-2016-03774
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    July 5, 2016
    Report Date
    July 5, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-8216-50 SERIAL #: (B)(4) DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM MODEL#: SC-4316 LOT#: 16920409 DESCRIPTION:NEXT GENERATION ANCHOR KIT-STERILE THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S SCS SYSTEM WAS NOT FUNCTIONING FOLLOWING A FALL. DATABASE ANALYSIS REVEALED EIGHT CONTACTS WITH HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S SCS SYSTEM WAS NOT FUNCTIONING FOLLOWING A FALL. DATABASE ANALYSIS REVEALED EIGHT CONTACTS WITH HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841233 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR