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

Model Number DTBA1D1

Device Problems Device Sensing Problem (2917); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Atrial Fibrillation (1729); Ventricular Tachycardia (2132)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 694965 lead, implanted: (b)(4)2007.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced ventricular tachycardia (vt).The patient's cardiac resynchronization therapy defibrillator (crt-d) initially withheld therapy due to the patient also being in atrial fibrillation (af) and the vt was detected as supra ventricular tachycardia (svt).The patient's af later terminated however therapy was still withheld due to the patient's stored qrs waveform.Withholding later stopped and therapy was delivered.It was also reported the patient became syncopal prior to therapy delivery.The crt-d was reprogrammed and remains in use.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 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: 7752174
• MDR Text Key: 116083337
• Report Number: 3004209178-2018-17443
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169007246
• UDI-Public: 00643169007246
• 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,health
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2015
• 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: 07/12/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• Date Device Manufactured: 03/06/2014
• 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
• Treatment: 5076-52 LEAD, 429688 LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 64 YR