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

Model Number DTMA2D4

Device Problems Pacing Problem (1439); Unable to Obtain Readings (1516); Output Problem (3005)

Patient Problem Weakness (2145)

Event Date 11/30/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during interrogation of the cardiac resynchronization therapy defibrillator (crt-d), markets were present, but no electrograms (egm) were visible and the device had no/low outputs.It was noted that it was impossible to perform any test on the device and obtain lead measurements.It was also noted that the patient had asthenia and a low junctional rhythm.The device was explanted and replaced.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 indicated the lead impedance data was missing/invalid.Analysis of the device memory indicated missing/invalid ca pture/threshold.Analysis of the device memory had an observation relating to pacing.Analysis of the device memory indicated the egm (electrogram) was not available.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.During the analysis of the returned device the failure on the hybrid disappeared.Device analysis confirmed the field allegations.Hybrid analysis revealed that there were at least four power on reset events, and the failure that was confirmed by the returned product analysis lab was cleared.The outputs were functional and lead measurements were nominal and product analysis lab tempe analysis did not confirm the failure, nor see any new power on resets.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLARIA MRI CRT-D SURESCAN
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9474829
• MDR Text Key: 170934414
• Report Number: 9614453-2019-04253
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2020

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: 08/28/2017
• Device Model Number: DTMA2D4
• Device Catalogue Number: DTMA2D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 12/17/2019; 05/15/2020
• Supplement Dates FDA Received: 12/18/2019; 05/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2016
• 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: (B)(4) LEAD, (B)(4) LEAD, (B)(4) LEAD
• Patient Outcome(s): Hospitalization; Required Intervention