BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4201359 · Received October 27, 2014

    Report

    Report Number
    3006630150-2014-02479
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-1110-02, SERIAL #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG). ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT OPTED TO HAVE THE LEAD REMAINED IMPLANTED. THE PATIENT WILL UNDERGO AN EXPLANT OF THE IPG.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S EXPLANT PROCEDURE WAS CANCELLED DUE TO NON-DEVICE RELATED ACCIDENT. THERE WILL BE NO FURTHER COURSE OF ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR THE EXPLANT OF IPG WAS DUE TO TENDERNESS. IT WAS ALSO REPORTED THAT THERE WAS A POSSIBLE LEAD FRACTURE.

    Additional Manufacturer Narrative · 1

    IPG SC-1110-02: DEVICE EVALUATION INDICATED THAT THE IPG PASSED ALL REQUIRED TESTS PERFORMED AND NO ANOMALIES WERE FOUND. LEAD SC-8216-70: DEVICE EVALUATION INDICATED THAT THE PADDLE LEAD WAS CUT AND THE PADDLE WAS NOT RETURNED. THE COMPLAINT OF IMPEDANCE ANOMALIES COULD NOT BE VERIFIED. X-RAY INSPECTION FOUND NO FRACTURE ON THE REMAINING LEAD.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT OF THE IPG AND DID WELL POSTOPERATIVELY. MALFUNCTION WAS SUSPECTED WITH THE IPG.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT COULD NOT GET STIMULATION ON HER BACK. HIGH IMPEDANCES WERE NOTED. DATA BASE ANALYSIS REVEALED THAT HIGH IMPEDANCES WERE MEASURED ON SEVERAL ELECTRODES. THE PATIENT WAS PROVIDED WARRANTY REPLACEMENT FOR THE LEAD BUT THE PATIENT DECIDED NOT TO MOVE FORWARD WITH THE REVISION. NO FURTHER COURSE OF ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT COULD NOT GET STIMULATION ON HER BACK. HIGH IMPEDANCES WERE NOTED. DATA BASE ANALYSIS REVEALED THAT HIGH IMPEDANCES WERE MEASURED ON SEVERAL ELECTRODES. THE PATIENT WAS PROVIDED WARRANTY REPLACEMENT FOR THE LEAD BUT THE PATIENT DECIDED NOT TO MOVE FORWARD WITH THE REVISION. NO FURTHER COURSE OF ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT COULD NOT GET STIMULATION ON HER BACK. HIGH IMPEDANCES WERE NOTED. DATA BASE ANALYSIS REVEALED THAT HIGH IMPEDANCES WERE MEASURED ON SEVERAL ELECTRODES. THE PATIENT WAS PROVIDED WARRANTY REPLACEMENT FOR THE LEAD BUT THE PATIENT DECIDED NOT TO MOVE FORWARD WITH THE REVISION. NO FURTHER COURSE OF ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT COULD NOT GET STIMULATION ON HER BACK. HIGH IMPEDANCES WERE NOTED. DATA BASE ANALYSIS REVEALED THAT HIGH IMPEDANCES WERE MEASURED ON SEVERAL ELECTRODES. THE PATIENT WAS PROVIDED WARRANTY REPLACEMENT FOR THE LEAD BUT THE PATIENT DECIDED NOT TO MOVE FORWARD WITH THE REVISION. NO FURTHER COURSE OF ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT COULD NOT GET STIMULATION ON HER BACK. HIGH IMPEDANCES WERE NOTED. DATA BASE ANALYSIS REVEALED THAT HIGH IMPEDANCES WERE MEASURED ON SEVERAL ELECTRODES. THE PATIENT WAS PROVIDED WARRANTY REPLACEMENT FOR THE LEAD BUT THE PATIENT DECIDED NOT TO MOVE FORWARD WITH THE REVISION. NO FURTHER COURSE OF ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT COULD NOT GET STIMULATION ON HER BACK. HIGH IMPEDANCES WERE NOTED. DATA BASE ANALYSIS REVEALED THAT HIGH IMPEDANCES WERE MEASURED ON SEVERAL ELECTRODES. THE PATIENT WAS PROVIDED WARRANTY REPLACEMENT FOR THE LEAD BUT THE PATIENT DECIDED NOT TO MOVE FORWARD WITH THE REVISION. NO FURTHER COURSE OF ACTION WILL BE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684583 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention