MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTPA2QQ

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

Patient Problem Tachycardia (2095)

Event Date 02/12/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: 6935m62 lead, implanted: (b)(6) 2016.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 device discriminator designed to evaluate the stability of ventricular intervals to prevent inappropriate detection of atrial fibrillation (af) with rapid ventricular response as ventricular tachycardia (vt), inappropriately withheld therapy for vt after classifying it as supra ventricular tachycardia (svt).It was noted the patient was symptomatic during the episode.The discriminator was programmed off and the patient was started on antiarrhythmic medication.The following day the patient had long runs of vt without successful pace termination.The arrhythmia degenerated into ventricular fibrillation (vf) and was terminated with a shock.The left ventricular (lv) lead was reprogrammed in the hopes of decreasing premature ventricular contractions (pvc) burden and vt.It was noted that the lv lead was challenging to place in a location with capture.The lead was ultimately placed in a location with capture, however, the threshold was high.Two days later the patient presented to the emergency room due to a shock.The lv lead was programmed of.The device and lead remains in use. the patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.

• Brand Name: COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• 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: 18959153
• MDR Text Key: 338356249
• Report Number: 9614453-2024-01146
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000178093
• UDI-Public: 00763000178093
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DTPA2QQ
• Device Catalogue Number: DTPA2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Date Device Manufactured: 11/08/2023
• 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: 5076-52 LEAD, 479888 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White