MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS GE MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM; DIGITAL BREAST TOMOSYNTHESIS

Model Number 5462139

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Transient Ischemic Attack (2109)

Event Date 09/20/2019

Event Type  Injury  

Event Description

Attribute to gr.3 syncope.On friday (b)(6) 2019 subject (b)(6) had an episode of syncope during the mammogram procedure.She was taken to the emergency dept and admitted.She was discharged from the ed the same day.Dr (b)(6), thought pt/subject may have suffered a tia, but that was not documented in the ed notes as such.The pt has returned today ((b)(6) 2019) to complete her breast imaging.Pt was admitted to the emergency dept for treatment, and discharged the same day.

• Brand Name: GE MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM
• Type of Device: DIGITAL BREAST TOMOSYNTHESIS
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS
• MDR Report Key: 9156644
• MDR Text Key: 161492947
• Report Number: MW5090226
• Device Sequence Number: 1
• Product Code: OTE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 5462139
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 84