MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA MRI XT DR SURESCAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number DDMB1D4

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Mechanical Problem (1384); Over-Sensing (1438); Impedance Problem (2950)

Patient Problem Burn(s) (1757)

Event Date 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: (b)(4) lead.Implanted: (b)(6) 2007.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 oversensing associated with the right ventricular lead.Analysis of the device memory indicated the impedance of the right ventricular defibrillation coil was beyond the expected upper range.Analysis of the device memory indicated the impedance trend of the right ventricular pacing lead was variable.Analysis of the device memory indicated oversensing; due to non-physiologic signals/sensing integrity counter.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 Description

It was reported, that the implantable cardioverter defibrillator (icd) triggered the recommended replacement time (rrt) indicator, after delivering in excess of 80 appropriate shocks for incessant ventricular tachycardia (vt).During the changeout procedure when the device was removed from the pocket, discoloration of the icd was noted near the edges of the device closest in proximity to the right ventricular (rv) lead defibrillation coil.And the patient's tissue around the device also appeared "charred".Review of clinical data indicated a shift in can-to-coil.Impedance was noted following the shocks delivered for vt.And it was suspected that this may have been a result of the change in device and tissue properties, following the excessive number of shocks delivered.Additionally, the replacement procedure involved electrocautery, which was detected by the device as oversensing episodes and sensing integrity counter (sic), prior to detections being turned off later, during the procedure.Review of the information by qualified engineering personnel indicated, that the discoloration of the device is likely due to the large number of shocks delivered in a short period of time.And an observed mark on the icd post-replacement was highly suspicious of an arc mark due to a lead insulation breach.Lead impeda nces, sensing values, and thresholds were all within expected ranges through the old and new device at the time.So the rv lead remains in use with a new icd implanted.Due to the patient's clinical status at the time, no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.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.

• Brand Name: EVERA MRI XT DR SURESCAN
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 16716710
• MDR Text Key: 313227952
• Report Number: 3004209178-2023-04839
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169720497
• UDI-Public: 00643169720497
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2020
• Device Model Number: DDMB1D4
• Device Catalogue Number: DDMB1D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2018
• 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: 6935M55 LEAD
• Patient Age: 72 YR
• Patient Sex: Male