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

Model Number	2088TC/65
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an implant procedure, the helix of the right ventricular (rv) lead was deformed upon removal from the patient.As a result, the rv lead was not used and was replaced with a new lead.The patient was stable throughout the procedure.
Additional Manufacturer Narrative
The reported event of helix damage/deformed was confirmed.As received, a complete lead was returned in one piece for analysis.Visual inspection of the lead found the helix was extended and bent.X-ray examination found helix was bent consistent with procedural damage.The helix mechanism/extension length test could not be performed due to the bent helix.The cause of the reported event was isolated to the helix being bent.

• 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: 25012566
• Report Number: 2017865-2026-08669
• Device Sequence Number: 13190284
• Product Code: NVN
• UDI-Device Identifier: 05414734505055
• UDI-Public: (01)05414734505055(10)P000238009(17)280731
• Combination Product (Y/N): Y
• Initial Reporter Country: TH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: P000238009
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2025
• 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