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

Model Number DTMA2D1

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438); Device Contamination with Body Fluid (2317)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2021

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 right ventricular (rv) lead exhibited increased impedance and decreased r-wave.An alert triggered for out of range high impedance and oversensing of non-sustained ventricular tachycardia episodes and noise.Markers showed possible t-waveoversensing (twos).Rv coil impedance also increased slightly.Reprogramming was performed.The lead remains in use.It was also reported that the cardiac resynchronization therapy defibrillator (crt-d) exhibited electromagnetic interference.The device remains in use.No 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 oversensing due to electromagnetic interference/noise.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received noted a revision was performed.The pin was discovered to be completely in the port, but blood ingress was observed.Everything was tested multiple times with lead manipulation and all measurements were normal.The device and lead remain in use.

• 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 ; SZ 1131
• MDR Report Key: 11777950
• MDR Text Key: 249095114
• Report Number: 9614453-2021-01862
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2021
• Device Model Number: DTMA2D1
• Device Catalogue Number: DTMA2D1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6947 LEAD, 4480 LEAD, UW28D LEAD; 6947 LEAD, 4480 LEAD, UW28D LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR