MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA¿ XT DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	DDBB1D1
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
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 implantable cardioverter defibrillator (icd) delivered inappropriate shocked for atrial fibrillation (af) with rapid ventricular response which the device detected with very rapid conduction ventricular rates up to low 200s beats per minute (bpm) rather than ventricular tachycardia (vt) or ventricular fibrillation (vf).The patient was hospitalized and treated with an increase dosage of medication and reprogramming was performed.The patient is a participant in a clinical study.The device remainsin use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction: b5; imf (annex f) health impact codes.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 implantable cardioverter defibrillator (icd) delivered inappropriate shocks for atrial fibrillation (af) with rapid ventricular response which the device detected with very rapid conduction ventricular rates up to low 200s beats per minute (bpm) rather than ventricular tachycardia (vt) or ventricular fibrillation (vf).The patient was hospitalized and treated with an increased dosage of medication and reprogramming was performed.The patient is a participant in a clinical study.The device remains in use.No further patient complications have been reported as a result of this event.It was additionally reported that the patient's electrolytes were abnormal.

• Brand Name: EVERA¿ XT DR
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 20346856
• Report Number: 3004209178-2024-19514
• Device Sequence Number: 18193118
• Product Code: LWS
• UDI-Device Identifier: 00643169720404
• UDI-Public: 00643169720404
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: 07/14/2020
• Device Model Number: DDBB1D1
• Device Catalogue Number: DDBB1D1
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/23/2024
• Date Device Manufactured: 01/19/2019
• 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: 5076-45 LEAD, 694965 LEAD.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Male