MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL ST; NO MATCH

Model Number	1888TC/46
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's notifier was triggered due to high capture thresholds on the left ventricular (lv) lead.The patient was scheduled for an extraction.During the procedure, an insulation breach was observed on the right atrial (ra) lead.The rv lead came out as a result of the lv extraction.No malfunction was stated on the rv lead.The ra lead was extracted.All leads were replaced.There were no reported patient consequences.
Additional Manufacturer Narrative
Correction: section d4 primary unique device identification (udi) number.
Additional Manufacturer Narrative
Correction: section b5 statement should have included "low pacing lead impedance" on the lv lead.
Event or Problem Description
It was reported that the patient's notifier was triggered due to low pacing lead impedance and high capture thresholds on the left ventricular (lv) lead.The patient was scheduled for an extraction.During the procedure, an insulation breach was observed on the right atrial (ra) lead.The rv lead came out as a result of the lv extraction.No malfunction was stated on the rv lead.The ra lead was extracted.All leads were replaced.There were no reported patient consequences.

• Brand Name: TENDRIL ST
• Common Device Name: NO MATCH
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24135997
• Report Number: 2017865-2026-01375
• Device Sequence Number: 13362189
• Product Code: NVN
• UDI-Device Identifier: 05414734501743
• UDI-Public: (01)05414734501743(10)3380570(17)140430
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/09/2026

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 Expiration Date: 04/30/2014
• Device Model Number: 1888TC/46
• Device Lot Number: 3380570
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 02/22/2026; 02/22/2026; 02/25/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/22/2026; 02/22/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2011
• 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: DURATA RV LEAD.; UNIFY ASSURA ICD.
• Patient Sex: Male