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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING INC. BRAVO RECORDER WITH ACCUVIEW SOFTWARE; ELECTRODE, PH, STOMACH
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GIVEN IMAGING INC. BRAVO RECORDER WITH ACCUVIEW SOFTWARE; ELECTRODE, PH, STOMACH Back to Search Results
Model Number FGS-0450
Device Problems Device Displays Incorrect Message (2591); Data Back-Up Problem (2902); Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/25/2017
Event Type  malfunction  
Event Description
Pt.Had bravo placed in egd (esophagogastroduodenoscopy).Pt.Returned bravo three days later.The bravo recorder uploaded without difficulty on the day it was returned.When md went to review bravo tracing 4 days after it was returned and uploaded, the file was missing from the computer.Spoke with the it department with given imaging.They were able to locate the patient's file right away, however it would not install on the accuview 6.0 software or the accuview 5.2 software.It states this patient's file has been corrupted and not able to look at any data collected.Clarification: the patient completed the 5 day device recording.The file was uploaded, however, when the md attempted to open the file a few days later, he was unable to locate the file.When it was found, an error message was received.When contacting medtronic they attempted to open the file with the current version software (accuview) and when that was unsuccessful they attempted to open it with the previous version software which was also unsuccessful.Additionally, it is not possible to go back to the recording device and "re-download" the information from the device.The manufacturer didn't seem to know what to make of the situation.The patient is very high-risk patient.Since the files could not be obtained, the patient is returning to his physician in approximately 1 week to discuss all available options.A repeat of the same test may mot be the most optimal choice.
 
Event Description
Pt.Had bravo placed in egd (esophagogastroduodenoscopy).Pt.Returned bravo three days later.The bravo recorder uploaded without difficulty on the day it was returned.When md went to review bravo tracing 4 days after it was returned and uploaded, the file was missing from the computer.Spoke with the it department with given imaging.They were able to locate the patient's file right away, however it would not install on the accuview 6.0 software or the accuview 5.2 software.It states this patient's file has been corrupted and not able to look at any data collected.Clarification: the patient completed the 5 day device recording.The file was uploaded, however, when the md attempted to open the file a few days later, he was unable to locate the file.When it was found, an error message was received.When contacting medtronic they attempted to open the file with the current version software (accuview) and when that was unsuccessful they attempted to open it with the previous version software which was also unsuccessful.Additionally, it is not possible to go back to the recording device and "re-download" the information from the device.The manufacturer didn't seem to know what to make of the situation.The patient is very high-risk patient.Since the files could not be obtained, the patient is returning to his physician in approximately 1 week to discuss all available options.A repeat of the same test may mot be the most optimal choice.
 
Event Description
Pt.Had bravo placed in egd (esophagogastroduodenoscopy).Pt.Returned bravo three days later.The bravo recorder uploaded without difficulty on the day it was returned.When md went to review bravo tracing 4 days after it was returned and uploaded, the file was missing from the computer.Spoke with the it department with given imaging.They were able to locate the patient's file right away, however it would not install on the accuview 6.0 software or the accuview 5.2 software.It states this patient's file has been corrupted and not able to look at any data collected.Clarification: the patient completed the 5 day device recording.The file was uploaded, however, when the md attempted to open the file a few days later, he was unable to locate the file.When it was found, an error message was received.When contacting medtronic they attempted to open the file with the current version software (accuview) and when that was unsuccessful they attempted to open it with the previous version software which was also unsuccessful.Additionally, it is not possible to go back to the recording device and "re-download" the information from the device.The manufacturer didn't seem to know what to make of the situation.The patient is very high-risk patient.Since the files could not be obtained, the patient is returning to his physician in approximately 1 week to discuss all available options.A repeat of the same test may mot be the most optimal choice.
 
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Brand Name
BRAVO RECORDER WITH ACCUVIEW SOFTWARE
Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
GIVEN IMAGING INC.
15 hampshire street
mansfield MA 02048
MDR Report Key6529453
MDR Text Key73939696
Report Number6529453
Device Sequence Number1
Product Code FFT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 04/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Unknown
Device Model NumberFGS-0450
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/26/2017
Device Age1 DY
Event Location Outpatient Diagnostic Facility
Date Report to Manufacturer04/26/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/28/2017
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received05/04/2017
05/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO; NO; THE BRAVO IMPLANTABLE DEVICE IS LOT- 338910, ID E9
Patient Age65 YR
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