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 Battery Problem (2885); Impedance Problem (2950)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

It was reported that the right ventricular (rv) lead defib impedance had dropped and that low pacing impedance was noted.The rv lead also exhibited increased thresholds but were stable.It was also reported that the left ventricular (lv) lead exhibited high thresholds.It was later reported that high and variable lv thresholds were potentially causing loss of capture at times and impacting battery longevity of the cardiac resynchronization therapy defibrillator (crt-d).Reprogramming of the lv lead was attempted but was unsuccessful.The rv lead exhibited high thresholds.It was also noted that the drop in rv defibrillation impedance was possibly due to a crt-d programming setting where the superior vena cava (svc) defibrillation coil was programmed on when the rv lead did not have an svc coil.The defibrillation impedance dropped in half when the svc coil was programmed off.The crt-d and leads remains in use.No patient complications have been reported as a result of this event.

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.

• 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: 19030710
• MDR Text Key: 339216446
• Report Number: 9614453-2024-01317
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2023
• Device Model Number: DTPA2QQ
• Device Catalogue Number: DTPA2QQ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/03/2024
• Date Device Manufactured: 02/03/2022
• 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: 5076-45 LEAD, 6935M55 LEAD, 429888 LEAD
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 83 KG