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

Model Number DTPB2Q1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Fluid Discharge (2686); Swelling/ Edema (4577)

Event Date 11/22/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced an infection of their cardiac resynchronization therapy defibrillator (crt-d) pocket.During normal follow up it was discovered that the patient had redness, swelling, and discharge at incision site.The crt-d system was explanted and replaced with a leadless implantable pulse generator (ipg) and the patient was administered antibiotics.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: 459888 lead implanted: (b)(6) 2021.If information is provided in the future, a supplemental report will be issued.

• Brand Name: COBALT¿ 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: 12970459
• MDR Text Key: 282004701
• Report Number: 9614453-2021-04575
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000178185
• UDI-Public: 00763000178185
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/14/2021
• Device Model Number: DTPB2Q1
• Device Catalogue Number: DTPB2Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Date Device Manufactured: 05/14/2020
• 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: 694758 LEAD, 407645 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male