BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 5275584 · Received December 8, 2015

    Report

    Report Number
    3006630150-2015-03184
    Event Type
    Injury
    Date Received
    December 8, 2015
    Date of Event
    November 13, 2015
    Report Date
    November 13, 2015
    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 INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL THE DEVICES WERE REMOVED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2366-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR 3-6 LEAD, 70CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-4316, LOT #: 16325685, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE.

    Additional Manufacturer Narrative · 1

    A RETURNED PRODUCT ANALYSIS OF THE IPG INDICATED THAT THE IMPEDANCE OF THE ELECTRODE #26 WAS EXTREMELY LOW (0 OHM) WITH LOAD CONNECTED. THERE WAS ABNORMAL OUTPUT ON THE NODE AS THE DEVICE WAS DEPOSITING EXCESSIVE CHARGE ON THE OUTPUT. IT WAS DETERMINED THAT THE NODE WAS SHORTED TO THE VH NODE INSIDE THE SLAVE ASIC (U3). THE PATIENT'S PROFILE INDICATED THAT THE ELECTRODE WAS ASSIGNED TO A NEGATIVE TERMINAL (CATHODE). ANALYSIS OF SC-2366-70/1003409, 1003413, 1004420: INDICATED THAT THE LEAD WAS CUT, AND THE DISTAL END PORTION WAS NOT RETURNED. X-RAY INSPECTION FOUND NO CABLE BREAKAGE. THE RETURNED LEAD SC-2366-70/1005474 WAS ANALYZED AND NO ANOMALIES WERE FOUND. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR ALL OF THE EXPLANTED DEVICES INCLUDING LEAD SC-2366-70/1003427 REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY. ANALYSIS OF THE CLIK ANCHOR REVEALED THAT THERE WAS MISSING SILICONE MATERIAL FROM THE TORN EYELETS. IT WAS CONFIRMED THAT THE SILICONE HAD BEEN TORN WHEN THE CLIK ANCHOR WAS REMOVED AND THAT THE SILICONE WAS REMOVED FROM THE PATIENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO AN EXPLANT PROCEDURE DUE TO HER BODY REJECTING THE IMPLANT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO AN EXPLANT PROCEDURE DUE TO HER BODY REJECTING THE IMPLANT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO AN EXPLANT PROCEDURE DUE TO HER BODY REJECTING THE IMPLANT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO AN EXPLANT PROCEDURE DUE TO HER BODY REJECTING THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805367 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention