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

Model Number DTBA1D1

Device Problem Pacing Problem (1439)

Patient Problems Syncope (1610); Bradycardia (1751)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 6931-58 lead, implanted: (b)(6) 2005, 5024m-58 lead, implaned: (b)(6) 2002, 330-854 lead, implanted: (b)(6)1992.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced syncopal episodes.The cardiac resynchronization therapy defibrillator (crt-d) was pacing at about 40 beats per minute, as observed on the telemetry strip by emergency medical services (ems.) the device remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary : the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

It was later reported that due to the patient's low fluid volume, the sensing was optimized and no additional episodes of decreased heart rate have been reported.

• Brand Name: VIVA¿ XT CRT-D
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8733528
• MDR Text Key: 149161523
• Report Number: 3004209178-2019-12348
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169530140
• UDI-Public: 00643169530140
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2019

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: 09/14/2018
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 06/25/2019; 06/26/2019
• Supplement Dates FDA Received: 06/26/2019; 07/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2017
• 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: 1058T LEAD
• Patient Outcome(s): Life Threatening
• Patient Age: 80 YR