MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA¿ XT DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	DDBB1D4
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	01/17/2026
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 patient received inappropriate anti-tachycardia pacing therapy and multiple shocks for an episode detected in the ventricular fibrillation (vf) zone that was suspected to be atrial fibrillation (af) with rapid ventricular response (rvr).In addition, the icd detected atrial fibrillation (af)/atrial flutter, sinus tachycardia and wavelet suspected to be af with rvr.The icd also detected atrial fibrillation (af) suspected to be atrial flutter.The implantable cardioverter defibrillator (icd) remains in use.No further patient complications have been reported as a result of this event.
Event or Problem Description
It was reported that the patient received inappropriate anti-tachycardia pacing therapy and multiple shocks for an episode detected in the ventricular fibrillation (vf) zone that was suspected to be atrial fibrillation (af) with rapid ventricular response (rvr).The icd also detected atrial fibrillation (af) suspected to be atrial flutter.The implantable cardioverter defibrillator (icd) remains in use.No further patient complications have been reported as a result of this event.It was further reported that the device was replaced due to reaching elective replacement indicator (eri) and the patient was administered medication for rate control.
Event or Problem Description
It was further reported that the device was replaced due to reaching elective replacement indicator (eri) and the patient was administered medication for rate control.
Additional Manufacturer Narrative
Correction: b5.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.
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.

• Brand Name: EVERA¿ XT DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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--439 ; 7635269277
• MDR Report Key: 24269293
• Report Number: 3004209178-2026-01906
• Device Sequence Number: 10726686
• Product Code: LWS
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2026

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: 03/14/2016
• Device Model Number: DDBB1D4
• Device Catalogue Number: DDBB1D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2026
• Supplement Date Received by Manufacturer: 06/04/2026; 07/01/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 06/25/2026; 07/07/2026
• Date Device Manufactured: 09/16/2014
• 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: 6935M62 LEAD, 5076-52 LEAD; 6935M62 LEAD, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 66 YR
• Patient Sex: Male