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

Model Number DTBA1D1

Device Problem Invalid Sensing (2293)

Patient Problem Ventricular Tachycardia (2132)

Event Date 11/12/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant product(s): a 6947 lead, implanted: (b)(6) 2010, 4076 lead, implanted: (b)(6) 2010.A good faith effort will be made to obtain the applicable information relevant to the report.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) however when the device was interrogated, there were no episodes detected and no therapy delivery.The right ventricular lead sensitivity was reprogrammed.During the sensing test, the patient's blood pressure dropped so the test was stopped.The patient then experienced vt again - with no therapy delivery.The lead was reprogrammed and then the device detected the vt and delivered therapy, terminating the vt.It was then reported the lead was oversensing t waves, so it was reprogrammed to eliminate the oversensing.The information was discussed with the cardiologist to develop and plan of action, and the device and lead 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: 7258145
• MDR Text Key: 99583979
• Report Number: 3004209178-2018-02928
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2018

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: 04/28/2016
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2017
• Initial Date FDA Received: 02/08/2018
• Date Device Manufactured: 11/12/2014
• 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: 4396 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR