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 Purulent Discharge (1812); Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 08/05/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 5076-52 lead, implanted: (b)(6) 2022.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced an infection approximately one month after the implant of a cardiac resynchronization therapy defibrillator (crt-d) with an absorbable envelope.It was also noted there was pocket erosion and pus drainage from the pocket.Additionally, the transesophageal echocardiogram (tee) noted vegetations on the leads. the cardiac resynchronization therapy defibrillator (crt-d) system was explanted. no further patient complications have been reported as a result of this event.

• 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: 15304948
• MDR Text Key: 298761374
• Report Number: 9614453-2022-02639
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2023
• Device Model Number: DTMA1QQ
• Device Catalogue Number: DTMA1QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• Date Device Manufactured: 05/11/2022
• 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: 6935M62 LEAD, 459888 LEAD, CMRM6133 ENVELOPE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 129 KG