MAUDE Adverse Event Report: MPRI SPRINT FIDELIS; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number 694958

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Chest Pain (1776); Shock from Patient Lead(s) (3162)

Event Date 03/21/2024

Event Type  Injury  

Event Description

It was reported that the patient experienced chest pain.The right ventricular (rv) lead triggered a noise warning, a warning for high undefined impedance, and a lead integrity alert (lia) due for two or more high rate non-sustained episodes and sensing integrity counter (sic.The patient received two inappropriate shocks due to the noise or an artifact.The ra lead remains in use. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Continued from d10: dtma1d1 crt-d implanted: (b)(6) 2021 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that the patient experienced chest pain.The right ventricular (rv) lead triggered a noise warning, a warning for high undefined impedance, and a lead integrity alert (lia) due for two or more high rate non-sustained episodes and sensing integrity counter (sic.The patient received two inappropriate shocks due to the noise or an artifact.The rv lead exhibited loss of capture.The rv lead remains in use. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction: b5 and h6 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was further reported that the rv lead was reprogrammed.It was confirmed that the shocks were inappropriate.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SPRINT FIDELIS
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• 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: 19099872
• MDR Text Key: 340056207
• Report Number: 2649622-2024-10216
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2024

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: 11/26/2006
• Device Model Number: 694958
• Device Catalogue Number: 694958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/12/2024; 04/17/2024
• Supplement Dates FDA Received: 04/12/2024; 05/09/2024
• Date Device Manufactured: 02/15/2005
• 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: 419388 LEAD, 5076-45 LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 81 KG