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

Model Number DTBA1D1

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Invalid Sensing (2293)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 02/12/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: 5076 lead, implanted: (b)(6) 2002.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a remote transmission revealed the right atrial lead was possibly oversensing far-field r waves.It also showed an episode of ventricular fibrillation (vf) where one shock was delivered, which terminated the episode as well as the atrial arrhythmia, so it was speculated the device may have delivered therapy due to atrial fibrillation with rapid ventricular conduction.Follow-up with the physician's office was attempted but no information could be obtained.The lead and device remain in use.No further 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 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: 7415305
• MDR Text Key: 105097966
• Report Number: 3004209178-2018-07169
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/10/2018

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: 03/14/2018
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 04/10/2018
• Date Device Manufactured: 09/24/2016
• 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): Life Threatening
• Patient Age: 89 YR