MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VISIA AF XT VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	DVAB1D1
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Low impedance (2285); Communication or Transmission Problem (2896); Impedance Problem (2950); Inappropriate or Unexpected Reset (2959); Reset Problem (3019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) experienced two power on resets (por) back-to-back just prior to a shock being delivered for a ventricular fibrillation (vf) episode.Following delivery of the shock there was a drop in right ventricular (rv) lead pacing impedance resulting in low out of range (oor) impedance alerts for both rv bipolar and rv tip to coil impedances.Additionally, it was noted that a week after the pors a shock was delivered with more that the programmed high voltage energy.During the following high voltage therapy delivery short circuit protection was triggered resulting in less than the programmed high voltage energy being delivered.In addition, wireless telemetry is no longer available.The implantable cardioverter defibrillator (icd) was replaced.No patient complications have been reported as a result of this event.
Event or Problem Description
It was further reported that the implantable cardioverter defibrillator (icd) was explanted prior to replacement and that the power on resets (por) were partial pors.
Additional Manufacturer Narrative
Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated a partial power on reset occurred.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was below the expected lower range.Analysis of the device memory indicated the impedance trend of the right ventricular pacing lead was decreasing.The device memory indicated the ventricular tachyarrhythmia therapy energy was high.Analysis of the device memory indicated that the ventricular tachyarrhythmia therapy energy was low.Analysis of the device memory indicated a wireless telemetry session was unable to be established.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.The feedthrough had current leakage (unspecified).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 indicated a partial power on reset occurred.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was below the expected lower range.Analysis of the device memory indicated the impedance trend of the right ventricular pacing lead was decreasing.The device memory indicated the ventricular tachyarrhythmia therapy energy was high.Analysis of the device memory indicated a wireless telemetry session was unable to be established.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.
Additional Manufacturer Narrative
Corrected: d6b.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: VISIA AF XT 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: 17827671
• Report Number: 3004209178-2023-16608
• Device Sequence Number: 2301985
• Product Code: LWS
• UDI-Device Identifier: 00643169566347
• UDI-Public: 00643169566347
• 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: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/19/2025

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: 04/14/2018
• Device Model Number: DVAB1D1
• Device Catalogue Number: DVAB1D1
• 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: 09/03/2023
• Supplement Date Received by Manufacturer: 09/28/2023; 08/29/2024; 03/11/2025
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/16/2023; 09/24/2024; 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2016
• 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: 694758 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male