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

Model Number DTBA1Q1

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

Patient Problems Discomfort (2330); Patient Problem/Medical Problem (2688)

Event Date 01/09/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 351337 lead implanted: (b)(6) 2007.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that since the cardiac resynchronization therapy defibrillator (crt-d) implant about 3.5 years earlier, the patient experiences a "thumping" sensation (an uncomfortable vibration with discomfort) each night on the left side around 23:52.The sensation lasts about 30 seconds and is regardless of patient position.Trouble-shooting was done by running various device features, with no obvious explanation, however further investigation pointed to capture management, so ths feature was programmed off.The device 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 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: 7714536
• MDR Text Key: 114852092
• Report Number: 3004209178-2018-16475
• 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: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2016
• Device Model Number: DTBA1Q1
• Device Catalogue Number: DTBA1Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 11/14/2014
• 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: 4298-88 LEAD, 5076-52 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR