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

Model Number DTMA1QQ

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

Patient Problems Abscess (1690); Erosion (1750); Unspecified Infection (1930)

Event Date 11/17/2021

Event Type  Injury  

Event Description

It was reported that there was a pocket infection with abscess that resulted in device erosion and required the cardiac resynchronization therapy defibrillator (crt-d) system removal.An implantable pulse generator (ipg) was implanted on the right side and connected to a preexisting right ventricular (rv) lead for pacing support.Blood cultures were negative times two per the physician.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: 310c31, tissue valve, implanted: (b)(6) 2020, 690r28, heart ring, implanted: (b)(6) 2020.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: 12913360
• MDR Text Key: 281582866
• Report Number: 9614453-2021-04476
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000059514
• UDI-Public: 00763000059514
• 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: 12/01/2021

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: 01/14/2022
• Device Model Number: DTMA1QQ
• Device Catalogue Number: DTMA1QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/01/2021
• Date Device Manufactured: 07/15/2020
• 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: 5076-52 LEAD, 459888 LEAD, 6935M62 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 138 KG