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

Model Number	2088TC/100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the atrial lead was explanted and replaced due to an unknown reason.The condition of the patient is unknown.
Additional Manufacturer Narrative
The reported event was ¿explanted and replaced due to an unknown reason¿.As received, only the distal portion of the lead was returned for analysis.Electrical testing that could be measured did not find any indication of conductor fractures or internal shorts.Visual inspection noted an external insulation abrasion breaching the outer insulation and exposing the outer coil at the proximal region of the lead consistent with friction to the device can.All other damages found are consistent with procedural damage.
Additional Manufacturer Narrative
Correction: section h6- investigation conclusions code should have been cause traced to component failure, instead of an unintended user error code.

• Brand Name: TENDRIL STS
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 20840189
• Report Number: 2017865-2024-71624
• Device Sequence Number: 3928256
• Product Code: NVN
• UDI-Device Identifier: 05414734505031
• UDI-Public: (01)05414734505031(10)P000053108(17)201031
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 01/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 2088TC/100
• Device Lot Number: P000053108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2024
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 12/19/2024; 01/01/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 12/22/2024; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2017
• 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: LEFT VENTRICULAR LEAD; RIGHT VENTRICULAR LEAD; UNIFY ASSURA ICD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 82 KG