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

Model Number DTBA1Q1

Device Problems Defibrillation/Stimulation Problem (1573); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Erythema (1840); Fatigue (1849); Dizziness (2194); Palpitations (2467)

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 4298-88 lead, implanted: (b)(6) 2015; 5076-45 lead, implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented for a device assessment after they experienced an irregular heartbeat, along with palpitations, fatigue and dizziness.It was noted that the patient had been experiencing worsening episodes of fatigue and recurrent palpitations, along with a drop in heart rate as low as 30 to 40 beats per minute and as high as 140 beats per minute.In addition, the patient had indicated that their cardiac resynchronization therapy defibrillator (crt-d) "did not fire" and required cardioversion in the emergency room.The patient was scheduled for an ablation procedure and received medication.The physician stated the patient may have a possibly malfunctioning device.The crt-d remains in use and the outcome was considered resolved.The patient is a participant in the adapt response clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIVA QUAD 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7728477
• MDR Text Key: 115294578
• Report Number: 3004209178-2018-16869
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169018013
• UDI-Public: 00643169018013
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2016
• Device Model Number: DTBA1Q1
• Device Catalogue Number: DTBA1Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 03/11/2015
• 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: 6949-65 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 94