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

Model Number DTBA1Q1

Device Problem Capturing Problem (2891)

Patient Problems Syncope (1610); Fall (1848); Laceration(s) (1946); Weakness (2145)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 694765 lead; 5568-53 lead, implanted: (b)(6) 2009.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient became dizzy, passed out, developed a laceration at the eyebrow, and felt weak.Interrogation of the cardiac resynchronization therapy defibrillator (crt-d)  showed ventricular tachycardia that was just below the threshold for shocking.Re-programming was performed, and the crt-d remains in use.The patient is a participant in the post approval clinical surveillance product surveillance registry.No further patient complications have been reported as a result of this event.

• Brand Name: VIVA QUAD 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: 8009362
• MDR Text Key: 125144996
• Report Number: 3004209178-2018-23999
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169018013
• UDI-Public: 00643169018013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2016
• Device Model Number: DTBA1Q1
• Device Catalogue Number: DTBA1Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2018
• Date Device Manufactured: 06/18/2015
• 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: 459888 LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 84