BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3895404 · Received June 25, 2014

    Report

    Report Number
    3006630150-2014-01402
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    May 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT IT WAS PHYSICIAN'S PREFERENCE TO REVISE THE LEADS. THE PATIENT WILL NOT UNDERGO A REVISION PROCEDURE. THERE WILL BE NO FURTHER COURSE OF ACTION AT THIS TIME. 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 Manufacturer Narrative · 1

    DATE OF IMPLANT: 2012. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL #:(B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING. THE IPG WAS NOT COMMUNICATING WITH THE CHARGER OR REMOTE CONTROL. THE PATIENT HAD A PREVIOUS SURGERY AND ELECTROCAUTERY MAY HAVE DAMAGED THE IPG. XRAY REVEALED THAT THE IPG HAD FLIPPED. THE PATIENT WILL UNDERGO A POCKET AND LEAD REVISION. THE REASON FOR LEAD REVISION IS UNKNOWN. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. (PHYSICIAN¿S IMPLANT MANUAL 9055940-001)

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING. THE IPG WAS NOT COMMUNICATING WITH THE CHARGER OR REMOTE CONTROL. THE PATIENT HAD A PREVIOUS SURGERY AND ELECTROCAUTERY MAY HAVE DAMAGED THE IPG. XRAY REVEALED THAT THE IPG HAD FLIPPED. THE PATIENT WILL UNDERGO A POCKET AND LEAD REVISION. THE REASON FOR LEAD REVISION IS UNKNOWN. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. (PHYSICIAN¿S IMPLANT MANUAL 9055940-001).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING. THE IPG WAS NOT COMMUNICATING WITH THE CHARGER OR REMOTE CONTROL. THE PATIENT HAD A PREVIOUS SURGERY AND ELECTROCAUTERY MAY HAVE DAMAGED THE IPG. XRAY REVEALED THAT THE IPG HAD FLIPPED. THE PATIENT WILL UNDERGO A POCKET AND LEAD REVISION. THE REASON FOR LEAD REVISION IS UNKNOWN. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. (PHYSICIAN¿S IMPLANT MANUAL 9055940-001)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370468 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention