MAUDE Adverse Event Report: GIVEN IMAGING LTD BRAVO PH CAPSULE DELIVERY DEVICE; ELECTRODE, PH, STOMACH

Model Number FGS-0313

Device Problem Compatibility Problem (2960)

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

Event Date 04/06/2016

Event Type  Injury  

Manufacturer Narrative

Reference#: (b)(4).The sample has been requested but to date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

Customer reported removal of the bravo capsule after placing it.The patient had a pacemaker.Physician confirmed that this was a contraindication after having placed the bravo capsule.

• Brand Name: BRAVO PH CAPSULE DELIVERY DEVICE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD; 2 hacarmel st.; p.o. box 258; new industrial park, yoqneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD; 2 hacarmel st.; p.o. box 258; new industrial park, yoqneam 20692 ; IS 20692
• Manufacturer Contact: sharon murphy ; 540 oakmead parkway; sunnyvale, CA 94085 ; 2034925267
• MDR Report Key: 5651029
• MDR Text Key: 45049429
• Report Number: 9710107-2016-00168
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention