MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL EVERA MRI S DR SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	DDMC3D4
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Device Sensing Problem (2917)
Health Effect - Clinical Codes	Dyspnea (1816); Abdominal Distention (2601); Heart Failure/Congestive Heart Failure (4446); Peripheral Edema (4578)
Date of Event	03/07/2024
Type of Reportable Event	Death
Additional 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.
Event or Problem Description
It was reported that the right ventricular (rv) lead triggered lead integrity alert (lia) for sensing integrity counter (sic) and high rate non-sustained episodes.The rv lead was also stated to be oversensing.It was further reported that the lia was suspected to be triggered due to t-wave oversensing (twos), and an atrial high rate episode was labeled ventricular tachycardia (vt) due to oversensing of noise.It was further reported that the patient's implantable cardioverter defibrillator (icd) inappropriately labeled an episode of sustained vt as supra ventricular tachycardia (svt).The patient had reported shortness of breath, abdominal distention and peripheral edema.After a family consultation, the device was deactivated with use of a magnet.The patient passed away the next day.
Additional 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 had an observation relating to supra ventricular tachycardia (svt) detection.Analysis of the device memory indicated the device failed to deliver a shock.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: EVERA MRI S DR SURESCAN
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• 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: 19124290
• Report Number: 9614453-2024-01515
• Device Sequence Number: 15516213
• Product Code: LWS
• UDI-Device Identifier: 00763000059705
• UDI-Public: 00763000059705
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/14/2023
• Device Model Number: DDMC3D4
• Device Catalogue Number: DDMC3D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6947M55 LEAD, 5076-45 LEAD.
• Outcome Attributed to Adverse Event: Hospitalization; Death; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female