BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2900486 · Received January 7, 2013

    Report

    Report Number
    3006630150-2012-02484
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    February 29, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE IPG 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

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: ST LINEAR LEAD, 50CM MODEL #: SC-2218-50E, SERIAL #: (B)(4), DESCRIPTION: ST LINEAR TRIAL LEAD, 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS UNABLE TO CHARGE THE IPG AND WAS EXPERIENCING POCKET SITE PAIN. THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE WHEREIN THE PHYSICIAN ELECTED TO REPLACE THE IPG AND LEADS. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN UNCOMFORTABLE STIMULATION. HIGH IMPEDANCES WERE NOTED ON 8 CONTACTS. THE PATIENT WAS ALSO UNABLE TO CHARGE THE IPG AND WAS EXPERIENCING POCKET SITE PAIN. THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE WHEREIN THE PHYSICIAN ELECTED TO REPLACE THE IPG AND LEADS. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN UNCOMFORTABLE STIMULATION. HIGH IMPEDANCES WERE NOTED ON 8 CONTACTS. THE PATIENT WAS ALSO UNABLE TO CHARGE THE IPG AND WAS EXPERIENCING POCKET SITE PAIN. THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE WHEREIN THE PHYSICIAN ELECTED TO REPLACE THE IPG AND LEADS. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7191 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention