MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL CLARIA MRI CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMA2D4

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that one day post implant of the right atrial (ra) lead, the device was interrogated with the programmer.The hospital technician did not hear the usual magnet audible tone when the programmer header was applied.The device was functioning appropriately at the check and she was able to demonstrate the alert tones to the patient in the same interrogation session with no issues.The device remains in use.No patient complications have been reported as a result of this event.

• Brand Name: CLARIA MRI CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 8091267
• MDR Text Key: 127947369
• Report Number: 9614453-2018-04120
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2018
• Device Model Number: DTMA2D4
• Device Catalogue Number: DTMA2D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2018
• 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
• Removal/Correction Number: Z-0962-2017
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 85