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

Model Number DTMA1Q1

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

Patient Problems Cellulitis (1768); Erythema (1840); Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Swelling/ Edema (4577)

Event Date 08/17/2022

Event Type  Injury  

Event Description

It was reported that 1 weeks post generator change out the patient presented to the clinic with redness around the implant site.Over the next few weeks the site became red/pink, itchy, swollen, and painful.The physician suspected cellulitis and notes dictate blood cultures were negative.The cardiac resynchronization therapy defibrillator (crt-d) system was explanted due to infection and a temporary pacemaker and right ventricular (rv) lead were implanted.Antibiotics were administered.A new crt-d, right ventricular (rv) lead, and left ventricular (lv) lead were implanted 2 weeks later.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: 429888 lead; implanted (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLARIA MRI QUAD CRT-D 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: 15527920
• MDR Text Key: 301011217
• Report Number: 9614453-2022-03024
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000059590
• UDI-Public: 00763000059590
• 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: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2023
• Device Model Number: DTMA1Q1
• Device Catalogue Number: DTMA1Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/03/2022
• Date Device Manufactured: 07/06/2022
• 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: 407652 LEAD, 694765 LEAD
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 129 KG