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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC/GIVEN IMAGING, INC. BRAVO REFLUX PH CAPSULE: DEPLOYMENT DEVICE; ELECTRODE, PH, STOMACH
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MEDTRONIC/GIVEN IMAGING, INC. BRAVO REFLUX PH CAPSULE: DEPLOYMENT DEVICE; ELECTRODE, PH, STOMACH Back to Search Results
Lot Number 473368F
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/27/2020
Event Type  Injury  
Event Description
Bravo ph capsule placed and not found in esophagus at recheck with fiberoptic scope.Bravo ph capsule id (b)(4) lot #473368f placed in usual fashion by dr.Not visualized with reinsertion of scope to verify placement.Patient had forceful cough within a few seconds of the delivery device removal.Dr.Carefully ¿reinspected¿ entire egd tract and looked inside mouth and at vocal cords with scope and no capsule seen.Xrays ordered and pulmonologist consulted by phone by dr.Xray of abdomen and chest completed.Patient did well post procedure and was discharged to home.Capsule later found on floor-patient had expelled during forceful cough.Fda safety report id # (b)(4).
 
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Brand Name
BRAVO REFLUX PH CAPSULE: DEPLOYMENT DEVICE
Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
MEDTRONIC/GIVEN IMAGING, INC.
MDR Report Key9671208
MDR Text Key177974999
Report NumberMW5092747
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number473368F
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
Patient Weight113
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