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

Model Number	2088TC/65
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Unspecified Infection (1930)
Type of Reportable Event	Death
Event or Problem Description
It was reported that patient expired due to multisystem organ failure, septic shock, right middle cerebral artery (mca) stroke and ileus.There is no known allegation from a health professional that suggests the death was related to the device.No further information is available.
Additional Manufacturer Narrative
The reported events were patient deceased and infection.The lead was returned for analysis.Visual examination found no malfunctions.

• Brand Name: TENDRIL STS
• 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: 25640454
• Report Number: 2017865-2026-13263
• Device Sequence Number: 10022645
• Product Code: NVN
• UDI-Device Identifier: 05414734505055
• UDI-Public: (01)05414734505055(10)P000203147(17)270531
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

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 Model Number: 2088TC/65
• Device Lot Number: P000203147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2024
• 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: 76 YR
• Patient Sex: Male