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 02/11/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 419588 lead, implanted: (b)(6) 2010.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient received an inappropriate shock from the cardiac resynchronization therapy defibrillator (crt-d) for an atrial driven supra ventricular tachycardia (svt).The patient did not receive any medical intervention as a result of the event.The crt-d remains 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: 7414179
• MDR Text Key: 104936486
• Report Number: 3004209178-2018-07015
• 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
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2016
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2018
• Date Device Manufactured: 02/13/2015
• 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: 693558 LEAD, 4076-45 LEAD
• Patient Outcome(s): Life Threatening
• Patient Age: 66 YR