MAUDE Adverse Event Report: MEDTRONIC IRELAND DEFLECT; CATHETER, PERCUTANEOUS

Model Number	C315H4002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	03/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately one month implant of the cardiac resynchronization therapy defibrillator (crt-d) system, the patient experienced pericardial effusion with pain at implant site.It was also reported that a during the implant procedure the patient anticoagulated so possible with anticoagulant five attempts is related to the pericardial effusion.The patient was administered oral medication or additional medication was given or adjusted.The crt-d system remains in use.No further patient complications have been reported as a result of this event.The patient is a participant in a clinical study.
Additional Manufacturer Narrative
Concomitant medical products: right atrial (ra) lead, implanted: unknown.Left ventricular (lv) lead, implanted: unknown.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DEFLECT
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 14175764
• Report Number: 9612164-2022-01536
• Device Sequence Number: 3986307
• Product Code: DQY
• UDI-Device Identifier: 00613994749949
• UDI-Public: 00613994749949
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2022
• Device Model Number: C315H4002
• Device Catalogue Number: C315H4002
• Device Lot Number: 0010246720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 04/21/2022
• Date Device Manufactured: 05/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 09300079 LEAD, DTMB2QQ CRT-D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 121 KG