BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 5130388 · Received October 6, 2015

    Report

    Report Number
    3006630150-2015-02561
    Event Type
    Injury
    Date Received
    October 6, 2015
    Date of Event
    May 6, 2015
    Report Date
    June 15, 2015
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE IMPLANT SITE FROM THE PREVIOUS REVISION PROCEDURE THAT HE HAD.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT STILL HAD CHARGING DIFFICULTY AFTER THE IPG REVISION AND THAT THE IMPLANT DEPLETES QUICKLY. IT WAS ALSO REPORTED THAT THE PATIENT FELT THE IMPLANT MOVING INSIDE THE POCKET AND CAUSED THE PATIENT TO FEEL NAUSEA. THE NAUSEA OCCURRED INITIALLY WHEN THE PATIENT LEANED FORWARD BUT HAS PERSISTED SINCE THEN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WILL BE NO FURTHER COURSE OF ACTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG FAILED TO CHARGE AFTER THE PATIENT TWISTED HIS BACK. THE PATIENT FELT THE IPG HAS MIGRATED WHICH WAS CONFIRMED BY X-RAY RESULT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS SUTURED DOWN. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG FAILED TO CHARGE AFTER THE PATIENT TWISTED HIS BACK. THE PATIENT FELT THE IPG HAS MIGRATED WHICH WAS CONFIRMED BY X-RAY RESULT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS SUTURED DOWN. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG FAILED TO CHARGE AFTER THE PATIENT TWISTED HIS BACK. THE PATIENT FELT THE IPG HAS MIGRATED WHICH WAS CONFIRMED BY X-RAY RESULT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS SUTURED DOWN. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG FAILED TO CHARGE AFTER THE PATIENT TWISTED HIS BACK. THE PATIENT FELT THE IPG HAS MIGRATED WHICH WAS CONFIRMED BY X-RAY RESULT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS SUTURED DOWN. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660425 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention