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

Model Number	1688TC/46
Medical Device Problem Codes	Intermittent Capture (1080); High impedance (1291); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Voluntary medwatch received states that the right ventricular (rv) lead exhibited high out of range pacing impedance, noise oversensing and intermittent loss of capture.No changes or interventions were reported; the rv lead remained implanted.No patient consequences were reported.
Additional Manufacturer Narrative
Further information was requested but not received.

• Brand Name: TENDRIL SDX LEAD
• 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: 25423578
• Report Number: 2017865-2026-11801
• Device Sequence Number: 17639350
• Product Code: NVN
• UDI-Device Identifier: 05414734501989
• UDI-Public: (01)05414734501989(10)2864366(17)120930
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: 09/30/2012
• Device Model Number: 1688TC/46
• Device Lot Number: 2864366
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2009
• 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: ACCENT DR; TENDRIL SDX
• Patient Age: 64 YR
• Patient Sex: Female