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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC / GIVEN IMAGING INC. BRAVO DEVICE; ELECTRODE, PH, STOMACH
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MEDTRONIC / GIVEN IMAGING INC. BRAVO DEVICE; ELECTRODE, PH, STOMACH Back to Search Results
Lot Number 51759F
Device Problem Activation Problem (4042)
Patient Problem Insufficient Information (4580)
Event Date 05/25/2021
Event Type  Injury  
Event Description
The patient underwent an egd for bravo ph placement.This bravo ph capsule did not deploy correctly.This was recognized immediately upon re-inspection of the esophagus following deployment of the device.The bravo ph capsule was then retrieved successfully with a roth net.The patient did well and reported no issues after awakening, upon post-procedure assessment.The patient tolerated the procedure well, the capsule was obtained.Bravo device used that did not attach to the esophagus was lot# 51759f, id#8e063.This lot was not included in the medtronic recall.All devices included in the medtronic recall was removed from stock in march 2021.Fda safety report id# (b)(4).
 
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Brand Name
BRAVO DEVICE
Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
MEDTRONIC / GIVEN IMAGING INC.
MDR Report Key11938413
MDR Text Key254537891
Report NumberMW5101703
Device Sequence Number1
Product Code FFT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/01/2021
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 Health Professional
Device Lot Number51759F
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/03/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age73 YR
Patient Weight73
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