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

Model Number	1688TC/58
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient deceased.There is no known allegation from a health professional that suggests the death was related to the device.It was reported that the causes of death was congestive heart failure complicated by pneumonia in a person with chronic respiratory and renal failure, diabetes, coronary artery atherosclerosis and cardiomyopathy.

• Brand Name: TENDRIL SDX LEAD
• 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: 50721546
• Report Number: 2017865-2026-19225
• Device Sequence Number: 8494928
• Product Code: NVN
• UDI-Device Identifier: 05414734501996
• UDI-Public: (01)05414734501996(10)3619956(17)150228
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 1688TC/58
• Device Lot Number: 3619956
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2012
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 72 YR
• Patient Sex: Male