MAUDE Adverse Event Report: MPRI EPSILA EV¿ MRI SURESCAN¿; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number EV240163

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Under-Sensing (1661)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id dvea3e4 (evx600791s); product type: 0235-icd; implant date (b)(6) 2024.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 Description

It was reported that extravascular implantable cardioverter defibrillator (ev-icd) detected an episode of supra ventricular tachycar dia (svt) but the episode was suspected to be ventricular tachycardia (vt), delaying therapy.Additionally, the extravascular (ev) lead exhibited undersensing possibly delaying detection and therapy.An episode of oversensing with noise was observed.The device and lead remain in use. no further patient complications have been reported as a result of this event.

• Brand Name: EPSILA EV¿ MRI SURESCAN¿
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19000637
• MDR Text Key: 338923338
• Report Number: 2649622-2024-08588
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00763000369781
• UDI-Public: 00763000369781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P220012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EV240163
• Device Catalogue Number: EV240163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Date Device Manufactured: 01/12/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11...
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 82 KG