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 Pacing Problem (1439); Protective Measures Problem (3015)

Patient Problems Fatigue (1849); Pain (1994); Tachycardia (2095); Discomfort (2330)

Event Date 03/27/2023

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the patient that the cardiac resynchronization therapy defibrillator (crt-d) had an alert tone sound.There was also a device malfunction that sustained the patient at a high heart rate.The crt-d was not able to return the patient to a normal rate due to the frozen accelerometer settings and an issue with the calibration sensors.The patient felt pain, soreness from the heart, and exhaustion.The settings were changed on the device and it remains in use.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: 16728363
• MDR Text Key: 313188642
• Report Number: 9614453-2023-01283
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 03/27/2023
• 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: 6935M55 LEAD, 5076-45 LEAD, 429888 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male