MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) TENDRIL MRI; Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Model Number	LPA1200M/58
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented with an effusion noted on the right ventricular lead.The lead was explanted and replaced on (b)(6) 2026.No adverse patient consequences were reported.

• Brand Name: TENDRIL MRI
• Common Device Name: Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50576286
• Report Number: 2017865-2026-18533
• Device Sequence Number: 21405664
• Product Code: NVN
• UDI-Device Identifier: 05414734504638
• UDI-Public: (01)05414734504638(10)S000071186(17)201130
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P140033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 11/30/2020
• Device Model Number: LPA1200M/58
• Device Lot Number: S000071186
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2019
• 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: MRI CondTendril; QUARTET LEADS; Quadra Allure
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 237 LB