MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO VIVA QUAD XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBX1QQ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Congestive Heart Failure (1783)

Event Type  Injury  

Event Description

It was reported that a week following the implant procedure, the patient presented to the emergency room (er) with complaints of increasing shortness of breath.After evaluation, the patient was found to have significant congestive heart failure.She was admitted to the hospital for diuresis.The system remains implanted.The patient is enrolled in the attain performa clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This model number is not approved for distribution in the u.S., however, it is similar to a device marketed in the u.S.The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Concomitant medical products: 429888, implantable pacing lead, (b)(6) 2013.(b)(4).

• Brand Name: VIVA QUAD XT
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3617358
• MDR Text Key: 4160282
• Report Number: 3004209178-2014-02480
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2014
• Device Model Number: DTBX1QQ
• Device Catalogue Number: DTBX1QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2013
• Date Device Manufactured: 06/05/2013
• 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
• Treatment: 6935M62, IMPLANTABLE TACHY LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00081 YR