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

Model Number DTBA1QQ

Device Problem Capturing Problem (2891)

Patient Problems Cardiac Arrest (1762); Fall (1848); Hematoma (1884); Laceration(s) (1946); Dizziness (2194)

Event Date 02/03/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was lightheaded and fell.The patient subsequently went to the hospital due to laceration to the head and subdural hematoma.Device interrogation showed the patient had high and rapid elevating right ventricular (rv) lead threshold.Telemetry strip was observed with total loss of capture on both rv and left ventricular (lv) leads for an extended period of time.It was questioned if the loss of capture was rv capture management running and functioning rv only for a period of time.It was noted the patient was going home on hospice as a result of the fall that may have been result of asystole.The device was reprogrammed.The device and leads remain in use.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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8378964
• MDR Text Key: 137437372
• Report Number: 3004209178-2019-04249
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169007222
• UDI-Public: 00643169007222
• 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: 02/28/2019

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: 05/14/2017
• Device Model Number: DTBA1QQ
• Device Catalogue Number: DTBA1QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2019
• Initial Date FDA Received: 02/28/2019
• Date Device Manufactured: 11/17/2015
• 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: 5076-45 LEAD, 459888 LEAD, 6935M55 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR