MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) TENDRIL STS; NO MATCH

Model Number	2088TC/65
Medical Device Problem Codes	Break (1069); Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for an implant procedure.During the procedure, it was noted that the right ventricular (rv) lead exhibited high capture threshold, and upon removing the lead, the lead helix was noted to have over-torqued.The lead was not used, and a new lead was implanted.The patient was stable throughout the procedure.
Additional Manufacturer Narrative
The reported events were inadequate capture and the helix damaged.As received, a complete lead was returned for analysis.The reported event of inadequate capture was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.The reported event of a helix damaged was confirmed.Visual and x-ray inspection of the lead did not find any anomalies with the exception of procedural damage.

• 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: 24904163
• Report Number: 2017865-2026-07991
• Device Sequence Number: 18591790
• Product Code: NVN
• UDI-Device Identifier: 05414734505055
• UDI-Public: (01)05414734505055(10)P000207788(17)270731
• Combination Product (Y/N): Y
• Initial Reporter Country: TH
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2088TC/65
• Device Lot Number: P000207788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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
• Patient Sex: Unknown