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

Model Number	DVBC3D1
Medical Device Problem Codes	Premature Discharge of Battery (1057); Reset Problem (3019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was multiple electrical resets and premature battery depletion on the implantable cardioverter defibrillator (icd).It was also noted the patient experienced diaphragmatic stimulation, "jumping or twitching in the chest," and palpitations.The right ventricular (rv) lead remains in use.The device was explanted and replaced. no further patient complications have been reported as a result of this event.
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.
Additional Manufacturer Narrative
Product event summary: performance data collected from the device was received and analyzed.Analysis of the device memory indicated a full electrical reset.Analysis of the device memory showed the battery indicator signifying that it is time for device replacement.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
Product event summary: the device was returned and analyzed.The returned device indicated shorting/low impedance in the battery.Analysis of the hybrid revealed the device loss of telemetry and all functions were due to a severely depleted battery.Review of the save to disk data showed that there was an unexplained voltage drop beginning on 11 august 2025.The device was fully functional and operated under normal current drain when powered with an external supply.There was no evidence of a high current drain condition, and no hybrid anomalies were observed.Analysis of the battery revealed plated lithium was found to initiate from the battery case, extend under the head space insulator, and contact the cathode tab.Based on this, the premature battery depletion was determined to be the result of a plated lithium short between the battery case (negative polarity) and the cathode tab (positive polarity).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¿ S VR
• 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: 23373821
• Report Number: 3004209178-2025-18085
• Device Sequence Number: 10089325
• Product Code: LWS
• UDI-Device Identifier: 00643169017900
• UDI-Public: (01)00643169017900(17)170114
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2026

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: 01/14/2017
• Device Model Number: DVBC3D1
• Device Catalogue Number: DVBC3D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 10/27/2025; 01/20/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/10/2025; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2015
• 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: 694758 LEAD.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 79 KG