MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number D314TRG

Device Problems Pacing Problem (1439); Invalid Sensing (2293)

Patient Problem Ventricular Tachycardia (2132)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) feature, which is designed to withhold inappropriate ventricular detection if the rhythm displays characteristics of a supra ventricular tachycardia (svt) origin, did not allow antitachycardia pacing to be withheld for the ventricular tachycardia (vt) episode due to the ventricular rate being greater than the atrial rate.However, the patient does not have an atrial lead for assessment of atrial activity.Programming options were discussed and the device remains in use.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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7418520
• MDR Text Key: 105377696
• Report Number: 3004209178-2018-07604
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00613994677884
• UDI-Public: 00613994677884
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2013
• Device Model Number: D314TRG
• Device Catalogue Number: D314TRG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Date Device Manufactured: 06/06/2012
• 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 Age: 87 YR