MAUDE Adverse Event Report: ABBOTT TENDRIL STS; NO MATCH

Model Number	2088TC/65
Medical Device Problem Codes	Break (1069); Difficult to Fold, Unfold or Collapse (1254); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an initial implant procedure, the helix of the right ventricular (rv) lead was unable to extend.Apon visual inspection, the helix appeared to be damaged during the procedure.A new rv lead was successfully implanted to resolve event.The patient was stable with no consequences.
Additional Manufacturer Narrative
Correction: b5.
Event or Problem Description
During an initial implant procedure, the right ventricular (rv) lead was unable to advance down the catheter.Upon visual inspection, the helix appeared to be damaged during the procedure.A new rv lead was successfully implanted to resolve event.The patient was stable with no consequences.

• Brand Name: TENDRIL STS
• Common Device Name: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT MEDICAL; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 25258240
• Report Number: 2017865-2026-10704
• Device Sequence Number: 10535283
• Product Code: NVN
• UDI-Device Identifier: 05414734505055
• UDI-Public: (01)05414734505055(10)P000253486(17)290331
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: P000253486
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2026
• 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