BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3050331 · Received April 10, 2013

    Report

    Report Number
    3006630150-2013-00664
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-3400-30 SERIAL/LOT #: (B)(4), DESCRIPTION: 30 CM SPLITTER KIT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT¿S LEAD WAS ALSO SHOWING HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION WHEREIN THE WHOLE SYSTEM WAS REPLACED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #:SC-2316-50, SERIAL #: (B)(4), DESCRIPTION:INFINION 1X16 PERC LEAD KIT-50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NOT HAVE THE REVISION DUE TO NON DEVICE RELATED ISSUES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE. THE PHYSICIAN BELIEVED THAT THERE WAS A CURRENT GETTING OUT FROM THE DEVICE CAUSING THE PAIN. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO A REVISION TO CHANGE THE IPG AND THE SPLITTER.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE. THE PHYSICIAN BELIEVED THAT THERE WAS A CURRENT GETTING OUT FROM THE DEVICE CAUSING THE PAIN. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO A REVISION TO CHANGE THE IPG AND THE SPLITTER.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE. THE PHYSICIAN BELIEVED THAT THERE WAS A CURRENT GETTING OUT FROM THE DEVICE CAUSING THE PAIN. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO A REVISION TO CHANGE THE IPG AND THE SPLITTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148703 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention