MAUDE Adverse Event Report: MEDTRONIC, INC. PROTECTA XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number D314TRG

Device Problems Intermittent Capture (1080); Failure to Capture (1081); Pacing Problem (1439); High Capture Threshold (3266)

Patient Problems Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Dizziness (2194)

Event Type  Injury  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Without a lot number or device serial number, the manufacturing date cannot be determined.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ventricular asystole in a crt-d device.What is the mechanism? pacing clin electrophysiol.2019; 42:1243-1245.Doi: 10.1111/pace.13773.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding a case study around the mechanism of ventricular asystole in a cardiac resynchronization therapy defibrillator (crt-d).It was reported that the patient presented with several episodes of presyncope over the course of a month.The patient was admitted and upon admission, a 13 second pause was observed.Overall, the patient had stable vital signs, however, interrogation of their crtd showed right ventricular (rv) lead elevated threshold.Left ventricular (lv) lead pacing was inhibited to allow for a rv capture test, which was normal function, but the capture management threshold testing was unsuccessful which resulted in asystole.A telemetry strip also showed intermittent capture.Ultimately, the rv lead was explanted and replaced.No further patient complications have been reported as a result of this event.

• Brand Name: PROTECTA XT CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10107087
• MDR Text Key: 193421461
• Report Number: 2182208-2020-00996
• Device Sequence Number: 1
• Product Code: NIK
• 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,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: D314TRG
• Device Catalogue Number: D314TRG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 89 YR