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 Loss of consciousness (2418); Heart Block (4444)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 1158tc lead, implanted: (b)(6) 2008.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was found unresponsive.It was also noted by the healthcare professional that the patient had possible pulseless electrical activity occurring.There was electrical activity but with a weak pulse.An external implantable pulse generator (ipg) was used for recovery.There was a concern that there was a possible loss of capture versus possible pulseless electrical activity.The device remains in use.Also noted on the interrogation was an episode of high threshold on the atrial lead.The atrial lead remains in use.No further patient complications have been reported as a result of this event.

• 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: 11306985
• MDR Text Key: 231129042
• Report Number: 3004209178-2021-02303
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/10/2021

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: 09/28/2018
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/10/2021
• Date Device Manufactured: 04/09/2017
• 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: 694758 LEAD, 5076-45 LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 70