MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) TENDRIL SDX LEAD; No Match

Model Number	1688TC/46
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review was performed and review of the sterilization records confirmed normal sterilization cycles for the products.The device met specifications prior to leaving abbott manufacturing facilities.The results of the investigation are inconclusive since the device was not returned for analysis.
Event or Problem Description
It was reported that the patient presented to the hospital due to infection.Vegetation was identified on the right ventricular (rv) lead, previously capped rv lead, right atrial (ra) lead, and previously capped ra lead.The physician explanted the entire system, including the pacemaker and all associated leads.A new leadless dual-chamber pacemaker was implanted.The patient remained in stable condition.

• Brand Name: TENDRIL SDX LEAD
• Common Device Name: No Match
• 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: 25423040
• Report Number: 2017865-2026-11705
• Device Sequence Number: 10031583
• Product Code: NVN
• UDI-Device Identifier: 05414734501989
• UDI-Public: (01)05414734501989(10)2105224(17)090131
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2026
• 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): 06/08/2026

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: 01/31/2009
• Device Model Number: 1688TC/46
• Device Lot Number: 0002105224
• Was Device Available for Evaluation?: No
• 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: 05/22/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2006
• 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: ASSURITY PACEMAKER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female