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

Model Number DTMA1Q1

Device Problems Failure to Deliver Shock/Stimulation (1133); Device Sensing Problem (2917)

Patient Problem Tachycardia (2095)

Event Date 03/03/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10:  (b)(6) tissue valve implanted (b)(6) 2016; 694758 lead implanted (b)(6)2012; 5076-52 lead implanted (b)(6) 2008.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 the patient was symptomatic.Upon review it was noted that the cardiac resynchronization therapy defibrillator (crt-d) inappropriately withheld therapy for ventricular tachycardia (vt) episodes which were classified as supra ventricular tachycardia (svt) via the device feature that compares the patient¿s current qrs waveform to a collected and stored template of the patient¿s qrs waveform during sinus rhythm.It was also noted that the physician thought the device was classifying episodes as terminated when the events did not appear to be truly terminated clinically. the device is still in use.  no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction: b2; b5; e1-3; g2; imf (annex f) health impact code.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 the patient was symptomatic.Upon review it was noted that the cardiac resynchronization therapy defibrillator (crt-d) inappropriately withheld therapy for ventricular tachycardia (vt) episodes which were classified as supra ventricular tachycardia (svt) via the device feature that compares the patient¿s current qrs waveform to a collected and stored template of the patient¿s qrs waveform during sinus rhythm.It was also noted that the physician thought the device was classifying episodes as terminated when the events did not appear to be truly terminated clinically. the device is still in use. no further patient complications have been reported as a result of this event.It was additionally reported that the device feature was programmed off.

• Brand Name: CLARIA MRI QUAD CRT-D SURESCAN
• Type of Device: 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19000004
• MDR Text Key: 338878996
• Report Number: 3004209178-2024-08067
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169705760
• UDI-Public: 00643169705760
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• 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
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2018
• Device Model Number: DTMA1Q1
• Device Catalogue Number: DTMA1Q1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2024
• Date Device Manufactured: 11/29/2016
• 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: 479888 LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male