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

Model Number DTPA2D1

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Tachycardia (2095); Vomiting (2144); Dizziness (2194); Loss of consciousness (2418); Choking (2464)

Event Date 01/17/2024

Event Type  Injury  

Event Description

It was reported, by the patient's family member, that ever since a routine device change out the patient has "had terrible hot flashes and dizzy spells." the patient was shocked while being admitted, their heart rate "was stuck on 156," "was puking or choking," and then "went unresponsive." they stated "we really think there is a problem with the device." the cardiac resynchronization therapy defibrillator (crt-d) remains in use. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d10: 0125 lead implanted (b)(6) 2003 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 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: 18972109
• MDR Text Key: 338516899
• Report Number: 9614453-2024-01191
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000178147
• UDI-Public: 00763000178147
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DTPA2D1
• Device Catalogue Number: DTPA2D1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Date Device Manufactured: 11/21/2023
• 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, 1258T86 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Male