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

Model Number	DDBC3D4
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	04/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient reported feeling a shock.Review of a remote transmission showed the implantable cardioverter defibrillator (icd) attempted to deliver 13 shocks for three episodes of what was suspected to be atrial fibrillation (af) with rapid ventricular response detected in the ventricular fibrillation (vf) zone.Review of the data from the treated episodes showed short circuit protection (scp) was triggered for all 13 high-voltage therapies, resulting in no high-voltage energy or less than the programmed high-voltage energy being delivered.Further review of the device data showed evidence that the scp events were related to an icd issue as there was no indication of a lead integrity issue that would have caused the scp events.Detections were programmed off, and the icd was later explanted and replaced with normal lead testing noted via analyzer during the changeout. 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: the device was returned for analysis.Performance data collected from the device was received and analyzed.Analysis of the device memory indicated that the ventricular tachyarrhythmia therapy energy was low due to an unintended current pathway.Analysis of the device memory had an observation relating to the at/af detection with rapid ventricular response.Analysis of the device memory indicated unexpected delivery of ventricular tachyarrhythmia therapy.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.Analysis of the device memory indicated that the ventricular tachyarrhythmia therapy energy was low due to an unintended current pathway.The feedthrough had current leakage (unspecified).Device analysis confirmed the field observation which is consistent with an l404 reset.Optical microscopy and optical coherence tomography confirmed that there was feedthrough dadet and medical adhesive delamination that resulted in an unintentional current leakage path that resulted in field complaint observations.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 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: 19270174
• Report Number: 3004209178-2024-10609
• Device Sequence Number: 7411757
• Product Code: LWS
• UDI-Device Identifier: 00643169018020
• UDI-Public: 00643169018020
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2024

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: 03/14/2017
• Device Model Number: DDBC3D4
• Device Catalogue Number: DDBC3D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/09/2024; 08/22/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/04/2024; 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2182208-051023-001-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6935M62 LEAD, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male