MAUDE Adverse Event Report: MPRI SPRINT FIDELIS; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 694965

Device Problem Capturing Problem (2891)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 06/13/2022

Event Type  Injury  

Event Description

It was reported that multiple pauses, some as long as 4.5 seconds, in pacing were observed on the holter monitor.It was noted that the pauses are likely due to the left ventricular (lv) lead, which is in the right ventricular (rv) port, exhibiting a loss of capture or far field p wave oversensing.The lv lead remains in use.No further patient complications have been reported as a result of this event.It was further reported that the outputs of both the rv and lv leads were increased and both leads remains in use.It was also noted that the device feature that automatically monitors and adjusts pacing thresholds was turned off, and no further pauses were noted.

Manufacturer Narrative

Continuation of concomitant medical products: dtba1d1 crt-d, implanted: (b)(6) 2019.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.

Manufacturer Narrative

Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated pacing capture threshold in the right ventricle was unstable.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: SPRINT FIDELIS
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15142081
• MDR Text Key: 297029910
• Report Number: 2649622-2022-15114
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/27/2008
• Device Model Number: 694965
• Device Catalogue Number: 694965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2006
• 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: 419488 LEAD, 457453 LEAD,
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 73 KG