BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2907464 · Received January 10, 2013

    Report

    Report Number
    3006630150-2013-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT DUE TO DEVICE MALFUNCTION. THE PATIENT HAD A NON-DEVICE RELATED PROCEDURE AND WAS BELIEVED THAT ELECTROCAUTERY WAS USED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE. THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAS DECIDED NOT TO MOVE FORWARD AT THIS TIME. THE PATIENT WILL ADVICE ONCE HE IS DECIDED. 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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING INTERMITTENT STIMULATION AS WELL AS SPORADIC CHANGES IN INTENSITY. THE IPG WAS PREVIOUSLY EXPOSED TO ELECTROCAUTERY. THE FIELD CLINICAL ENGINEER (FCE) AND PHYSICIAN SUGGESTED TO HAVE THE PATIENTS IPG REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING INTERMITTENT STIMULATION AS WELL AS SPORADIC CHANGES IN INTENSITY. THE IPG WAS PREVIOUSLY EXPOSED TO ELECTROCAUTERY. THE FIELD CLINICAL ENGINEER (FCE) AND PHYSICIAN SUGGESTED TO HAVE THE PATIENTS IPG REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING INTERMITTENT STIMULATION AS WELL AS SPORADIC CHANGES IN INTENSITY. THE IPG WAS PREVIOUSLY EXPOSED TO ELECTROCAUTERY. THE FIELD CLINICAL ENGINEER (FCE) AND PHYSICIAN SUGGESTED TO HAVE THE PATIENTS IPG REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15844 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR