MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL EVERA MRI XT DR SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number DDMB1D4

Device Problems Signal Artifact/Noise (1036); Mechanical Problem (1384); Over-Sensing (1438); Capturing Problem (2891); Impedance Problem (2950); High Capture Threshold (3266)

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

Event Date 09/14/2023

Event Type  Injury  

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.

Event Description

It was reported that after the patient received appropriate therapy last year, the right ventricular (rv) lead impedances and capture thresholds were gradually trending upward.A lead alert had later triggered due to rv impedance variation and short v-v intervals.High capture thresholds were also noted.The rv lead polarity configuration was reprogrammed, and it was further noted that short v-v intervals were accumulating more frequently.There were non-sustained ventricular tachycardia (nsvt) episodes showing non-physiologic noise, however, isometric testing could not reproduce the noise.It was further reported that during a revision procedure, the physician pulled on the rv lead, and it came directly out of the implantable cardioverter defibrillator (icd).The decision was made to remove and replace icd due to the uncertainty of the set screw.The rv lead remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction: additional codes.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.

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 the impedance trend of the right ventricular pacing lead was rising.Analysis of the device memory indicated the impedance trend of the right ventricular defibrillation coil was rising.Analysis of the device memory indicated the impedance trend of the right ventricular defibrillation coil was variable.Analysis of the device memory indicated the impedance trend of the right ventricular pacing lead was variable.Analysis of the device memory indicated pacing capture threshold in the right ventricle was elevated.Analysis of the device memory indicated pacing capture threshold in the right ventricle was rising.Analysis of the device memory indicated noise.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.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 MRI XT DR SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19168362
• MDR Text Key: 340873778
• Report Number: 9614453-2024-01596
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00763000059491
• UDI-Public: 00763000059491
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2024
• Device Model Number: DDMB1D4
• Device Catalogue Number: DDMB1D4
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 04/23/2024; 04/26/2024
• Supplement Dates FDA Received: 04/23/2024; 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2022
• 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: 6935M62 LEAD, 507652 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female