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

Model Number	1688TC/52
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During analysis, a failure event was observed which was unrelated to the reported event.Final analysis found a complete lead was returned in two pieces.Visual inspection of the lead found external insulation abrasion that breached the outer insulation and exposed the outer coil at the distal region.The cause of external insulation abrasion is consistent with friction to another device or features of the heart.
Event or Problem Description
This report is to advise of an event observed during analysis.
Additional Manufacturer Narrative
Correction: h11: field should be: no complaint was received with the return of the device.Failure event observed during analysis.Final analysis found during analysis; a failure event was observed which was unrelated to the reported event.Final analysis found a complete lead was returned in two pieces.Visual inspection of the lead found external insulation abrasion that breached the outer insulation and exposed the outer coil at the distal region.The cause of external insulation abrasion is consistent with friction to another device or features of the heart.Correction: d4: primary unique device identification (udi) number should have been (b)(4) rather than (b)(4) as submitted in initial report submitted on (b)(6) 2026.

• 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: 25064097
• Report Number: 2017865-2026-09042
• Device Sequence Number: 13086554
• Product Code: NVN
• UDI-Device Identifier: 05414734501859
• UDI-Public: (01)05414734501859(10)3485323(17)140831
• 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
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: Other
• Device Expiration Date: 08/31/2014
• Device Model Number: 1688TC/52
• Device Lot Number: 3485323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/03/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2011
• 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
• Patient Sex: Unknown