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

Model Number	DVFC3D1
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Pacing Problem (1439); Under-Sensing (1661); Low impedance (2285); Capturing Problem (2891); Device Sensing Problem (2917); Impedance Problem (2950)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Tachycardia (2095); Ventricular Fibrillation (2130); No Consequences Or Impact To Patient (2199); Twiddlers Syndrome (4563); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2020
Type of Reportable Event	Serious Injury
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 right ventricular undersensing/no right ventricular sensing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that an alert was triggered due to low pacing impedance.A device transmission showed that the pacing impedance and threshold had been increasing prior to the alert.It was noted that the rv lead was not sensing and was unable to capture.The implantable cardioverter defibrillator (icd) was pacing without deflection on the electrogram and was unable to sense.The plan is to have patient get an x-ray to determine next steps.The device and lead remain in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction: h6.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 further reported that there had been a spike to high rv pacing impedance noted, and reprogramming was performed to change the pacing and sensing vectors.There were multiple rv lead alerts noted due to a drop to zero impedance in bipolar configuration.The patient was recently brought to the emergency room and had experienced cardiac arrest and unstable ventricular tachycardia/ventricular fibrillation (vt/vf).The patient received shock therapies from their device, however there were periods of ventricular undersensing observed.The patient required external defibrillation.An x-ray revealed that the patient appeared to have twiddler's syndrome.A review of device data by qualified personnel noted a flat and noisy line on the rv channel.The rv lead was inactivated and replaced.The icd was explanted and replaced.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Return date product event summary: the device was returned and analyzed.Returned product analysis 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.

• Brand Name: VISIA AF MRI S VR SURESCAN
• 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: 10076596
• Report Number: 3004209178-2020-08904
• Device Sequence Number: 2835944
• Product Code: LWS
• UDI-Device Identifier: 00643169837829
• UDI-Public: 00643169837829
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2024

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: 04/28/2021
• Device Model Number: DVFC3D1
• Device Catalogue Number: DVFC3D1
• 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: 04/28/2020
• Supplement Date Received by Manufacturer: 06/11/2024; 07/11/2024
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 06/28/2024; 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2019
• 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: 693565 LEAD; 693565 LEAD
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male