BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 6065173 · Received October 28, 2016

    Report

    Report Number
    3006630150-2016-03101
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED IPG (SC-1110-02/241641), SPLITTER (SC-3400-30/(B)(4)) AND CLIK ANCHOR (SC-4316/(B)(4)) WERE ANALYZED AND NO ANOMALIES WERE FOUND. SC-2316-50 (SN:(B)(4)) DEVICE EVALUATION INDICATED THAT THE COMPLAINT WAS CONFIRMED. VISUAL INSPECTION REVEALED THAT THE LEAD WAS CLEANLY CUT AT 24 CM FROM THE TIP OF PROXIMAL END. X-RAY INSPECTIONS FOUND NO CABLE BREAKAGE AND NO CABLES ARE EXPOSED. THE CLEAN CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. ADDITIONALLY THE DISTAL END IS MISSING. REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED POCKET PAIN. DAMAGE TO THE DEVICE WAS SIMILAR TO THE TYPICAL EXPLANT DAMAGE AND WAS NOT CONSIDERED A FAILURE. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-2316-50 SERIAL/LOT#: (B)(4), DESCRIPTION: INFINION 1X16 PERC LEAD KIT-50 CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG, LEAD, SPLITTER AND CLIK ANCHOR WERE REPLACED. MALFUNCTION WAS SUSPECTED ON LEADS DAMAGED BY SPLITTER AND NO MALFUNCTION SUSPECTED ON IPG. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAINFUL SHOCKS FROM THE SPINAL CORD STIMULATOR. IT WAS MENTIONED THAT THE IPG POCKET WAS VERY SORE AND HURTING TO TOUCH. HIGH IMPEDANCES WERE NOTED. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAINFUL SHOCKS FROM THE SPINAL CORD STIMULATOR. HIGH IMPEDANCES WERE NOTED. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAINFUL SHOCKS FROM THE SPINAL CORD STIMULATOR. IT WAS MENTIONED THAT THE IPG POCKET WAS VERY SORE AND HURTING TO TOUCH. HIGH IMPEDANCES WERE NOTED. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAINFUL SHOCKS FROM THE SPINAL CORD STIMULATOR. IT WAS MENTIONED THAT THE IPG POCKET WAS VERY SORE AND HURTING TO TOUCH. HIGH IMPEDANCES WERE NOTED. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714710 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention