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

Model Number DTPA2D4

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate or Unexpected Reset (2959)

Patient Problems Anxiety (2328); Shock from Patient Lead(s) (3162)

Event Date 03/18/2022

Event Type  Injury  

Event Description

It was reported that a lead integrity alert (lia) triggered due to high rate non sustained episode (hr-ns) and sensing integrity counter (sic), and all impedances were stable.It was suspected that the oversensing was due to cardiac resynchronization therapy defibrillator (crt-d) electromagnetic interference as the baseline noise appeared more like emi than lead noise.Troubleshooting was performed, no noise was reproduced in true bipolar or tip to coil and it was concluded the patient was resting during the times of the non-sustained ventricular tachycardia (ns-vt).There were four partial diagnostic resets and emi appeared to have occurred at the time of the partial resets.The patient indicated no electrical items around that could cause noise.Re-programming was performed with change from bipolar to tip-coil configuration on pace and sense, adjusted sensitivity, and extended atrioventricular delay.Additional information noted that six months prior, the patient had received inappropriate high voltage therapy.The patient received a 40-joule shock while at physical therapy using a functional electrical stimulation bike.The high voltage therapy was delivered due to emi.High rate ns, and sic was observed and noted to be unrelated to a lead issue and was due to emi with associated noise and artifacts.The patient expressed some anxiety related to receiving high voltage therapy.The patient vital signs taken following the high voltage therapy were within normal limits.As there was continued noise, provocative testing was performed however, the noise was unable to be reproduced.The crt-d and rv lead remain in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

383074 lead implanted: (b)(6)2021.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.If information is provided in the future, a supplemental report will be issued.

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 unexpected delivery of ventricular tachyarrhythmia therapy.Analysis of the device memory indicated the criteria for the right ventricular lead integrity alert were met.Analysis of the device memory indicated a partial power on reset occurred.Analysis of the device memory indicated oversensing due to electromagnetic interference/noise.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.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.

• Brand Name: COBALT¿ XT HF CRT-D MRI 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
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 16134290
• MDR Text Key: 307042509
• Report Number: 9614453-2023-00120
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000178130
• UDI-Public: 00763000178130
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/14/2023
• Device Model Number: DTPA2D4
• Device Catalogue Number: DTPA2D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2021
• 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: 5076-52 LEAD, 6935M62 LEAD
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 140 KG