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

Model Number DTMA1D1

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

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 03/29/2022

Event Type  Injury  

Event Description

It was reported that approximately three months post replacement procedure, the patient developed a pocket infection.It was noted that during the lead replacement procedure, when the physician opened the pocket, ¿puss¿ oozed out.The original plan was to explant and replaced the right ventricular (rv) lead due to high and undefined superior vena cava (svc) and rv coil impedance measurements.The physician and staff sent the swapped cultures, but the results were unknown during the procedure.The physician decided to remove the right atrial (ra) lead and rv lead and leave the two left ventricular (lv) leads implanted due to patient being dependent.The device was removed from the pocket but connected to the lv leads and remains in use externally.Antibiotic treatment was necessary.The lv leads and device was later removed, and a new cardiac resynchronization therapy pacemaker (crt-p) system was implanted.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id: 5071-53, product type: lead; product id: 5071-53, product type: lead; 5866-38m, adaptor implanted: (b)(6) 2008.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLARIA MRI 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: 14161311
• MDR Text Key: 289670838
• Report Number: 9614453-2022-01132
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000059552
• UDI-Public: 00763000059552
• 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: 04/20/2022

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: 03/28/2023
• Device Model Number: DTMA1D1
• Device Catalogue Number: DTMA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/20/2022
• Date Device Manufactured: 09/30/2021
• 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: 407645 LEAD, 694758 LEAD.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male