MAUDE Adverse Event Report: MEDTRONIC BRAVO PH CAPSULE; ELECTRODE, PH, STOMACH

Lot Number 45801F

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2019

Event Type  malfunction  

Event Description

After placement of bravo ph capsule in usual fashion, recorder device was unable to receive data from capsule.Attempted 2nd recorder and still unable to connect w/capsule to receive data.Contacted medtronic tech support who confirmed ph capsule not functioning.Procedure aborted.

• Brand Name: BRAVO PH CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 8955837
• MDR Text Key: 156558423
• Report Number: MW5089501
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2020
• Device Lot Number: 45801F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 84