MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. CLARIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number	DTMA1D1
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	03/16/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that during use of the cardiac resynchronization therapy defibrillator (crt-d), question was ask about patient's right ventricular oversensing.  it was indicated that will the patient was in office, it was noted that there had been an additional oversensing episode that the patient identified as likely due to external electromagnetic interference (emi) due to the patient using a drill at the time of the episode because the patient  started feeling dizzy while using the drill.  the crt-d remains in use.  no further patient complications have been reported as a result of this event.
Event or Problem Description
It was reported that during use of the cardiac resynchronization therapy defibrillator (crt-d), question was ask about patient's right ventricular oversensing.It was indicated that while the patient was in office, it was noted that there had been an additional oversensing episode that the patient identified as likely due to external electromagnetic interference (emi) due to the patient using a drill at the time of the episode because the patient started feeling dizzy while using the drill.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction: b5.Desc evt problem.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
Correction: h3.Device evaluated, h6.Eval code method (fdm/annex b), eval code result (fdr/annex c), eval code conclusion (fdc/annex d).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
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 observed noise on the electrogram waveforms.Analysis of the device memory indicated emi.Analysis of the device memory indicated oversensing.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CLARIA MRI CRT-D SURESCAN
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• 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: 19359103
• Report Number: 3004209178-2024-11321
• Device Sequence Number: 3728201
• Product Code: NIK
• UDI-Device Identifier: 00643169837676
• UDI-Public: 00643169837676
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/18/2024

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: 01/14/2020
• Device Model Number: DTMA1D1
• Device Catalogue Number: DTMA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 05/21/2024; 05/21/2024; 05/31/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 05/21/2024; 05/21/2024; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2018
• 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: 5076-45 LEAD, 694865 LEAD, 419478 LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male