MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA1D1

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

Patient Problem Pulmonary Edema (2020)

Event Date 05/26/2015

Event Type  Injury  

Event Description

It was reported that follow implant of the cardiac resynchronization therapy-defibrillator (crt-d), the patient developed moderate interstitial pulmonary edema.The patient developed rhonchorous upper airway sounds at the end of implant procedure requiring suctioning.Post procedure additional suctioning was required.The patient developed decreased oxygen saturation when attempting to cough u p secretions.Chest x-ray confirmed diffuse increased prominence of interstitial and pulmonary markings compatible with edema.The patient was admitted for overnight observation.The patient was treated by nebulizer and the edema was noted as resolved the following day.A chronic right ventricular (rv) lead and left ventricular (lv) lead remain in use.The crt-d remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Event Description

It was reported that follow implant of the cardiac resynchronization therapy-defibrillator (crt-d), the patient developed moderate interstitial pulmonary edema.The patient developed rhonchorous upper airway sounds at the end of implant procedure requiring suctioning.Post procedure additional suctioning was required.The patient developed decreased oxygen saturation when attempting to cough up secretions.Chest x-ray confirmed diffuse increased prominence of interstitial and pulmonary markings compatible with edema.The patient was admitted for overnight observation.The patient was treated by nebulizer and the edema was noted as resolved the following day.A chronic right ventricular (rv) lead and left ventricular (lv) lead remain in use.The crt-d remains in use.The patient is enrolled in the wrap_it (world-wide randomized antibiotic envelope infection prevention trial ) study.No patient complications have been reported as a result of this event.

• Brand Name: VIVA XT
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• 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: 4968156
• MDR Text Key: 6253105
• Report Number: 3004209178-2015-15099
• 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,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2016
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2015
• Date Device Manufactured: 10/03/2014
• 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; Life Threatening; Required Intervention
• Patient Age: 00079 YR