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

Model Number DTBA1D1

Device Problems Electrical /Electronic Property Problem (1198); Pacing Problem (1439)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 06/03/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 694965 lead, implanted (b)(6) 2005; 419488 lead, implanted: b)(6) 2005.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient had issues with diaphragmatic stimulation for many years.The left ventricular (lv) lead was ultimately programmed off.The patient presented again with complaints of diaphragmatic stimulation.It was noted that the device was still biventricular pacing due to device feature that is designed to maintain cardiac resynchronization therapy pacing in the presence of ventricular sensing.The device feature was turned off and the patient showed ventricular oversensing of the atrial pace and did not provide right ventricular pacing.The device feature was programmed back on.The lead and device remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: VIVA XT CRT-D
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12051210
• MDR Text Key: 260368670
• Report Number: 3004209178-2021-09837
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169530140
• UDI-Public: 00643169530140
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/23/2021

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: 07/14/2018
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/23/2021
• Date Device Manufactured: 01/19/2017
• 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): Required Intervention
• Patient Age: 84 YR