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

Model Number	DVBC3D4
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the clinic after hearing device tones.The clinician was unable to make telemetry with the implantable cardioverter defibrillator (icd) via multiple programmers, and was unable to hear any tones when using a magnet directly on the device.The most recent interrogation report from the end of (b)(6) 2024 indicated that there was 2.2 years of battery life left.The physician determined the device was dead and the patient was sent directly to the emergency room for same day changeout in lab.Premature battery depletion was suspected.The patient was admitted to hospital and attempts were made again to establish telemetry with icd without success.Patient was then prepped for a device change out.The icd was explanted and replaced.No 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: the device was returned for analysis, and full device analysis is currently underway.Performance data collected from the device was received and analyzed.Analysis of the device memory was performed and no anomalies were found.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.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 ; 7635269277
• MDR Report Key: 19070295
• Report Number: 3004209178-2024-08714
• Device Sequence Number: 4658365
• Product Code: LWS
• UDI-Device Identifier: 00643169017887
• UDI-Public: 00643169017887
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2024

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: 08/14/2015
• Device Model Number: DVBC3D4
• Device Catalogue Number: DVBC3D4
• 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: 03/22/2024
• Supplement Date Received by Manufacturer: 04/22/2024; 07/22/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/07/2024; 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1305-2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6947M62, LEAD.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male