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

Model Number DTPA2Q1

Device Problems Mechanical Problem (1384); Misconnection (1399)

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

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 414005 lead implanted (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) exhibited a grommet or setscrew issue.The physician was noted to have experienced connection issues with the crt-d and lead at implant.High lead impedance that would change with pocket manipulation was noted approximately one week post-implant.Reprogramming was performed and the crt-d remains in use.No 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: 12414311
• MDR Text Key: 269545180
• Report Number: 9614453-2021-03429
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000178109
• UDI-Public: 00763000178109
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2021
• Device Model Number: DTPA2Q1
• Device Catalogue Number: DTPA2Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2021
• Date Device Manufactured: 03/10/2020
• 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: 459888 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR