MAUDE Adverse Event Report: IPG MFG SWITZERLAND BRAVA QUAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBC2Q1

Device Problems Over-Sensing (1438); Device Contamination with Body Fluid (2317)

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

Event Date 05/16/2014

Event Type  Injury  

Event Description

It was reported that following the implant procedure, oversensing was noted approximately 10 minutes after the right atrial (ra) lead had been inserted into the device header.The pocket was re-opened and blood was noted in the atrial port.The area was cleaned and the lead re-inserted with no further oversensing detected.Five minutes later, oversensing was again noted on the atrial electrogram.The device was removed from the pocket and blood could once again be seen in the atrial port.The physician decided to remove the device and replaced with a new device successfully.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Product event summary: the device was returned and analyzed.Analysis was performed and no anomalies were found.(b)(4).

• Brand Name: BRAVA QUAD
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 3989173
• MDR Text Key: 20266985
• Report Number: 9614453-2014-01662
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2015
• Device Model Number: DTBC2Q1
• Device Catalogue Number: DTBC2Q1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2014
• Initial Date FDA Received: 08/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention