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

Model Number 1888TC/58

Device Problem Device Sensing Problem (2917)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The reported event of a sensing issue was confirmed.As received, a partial lead was returned in two portions for analysis.Visual inspection found, a full breach outer insulation degradation adjacent to the connector boot.And an external insulation abrasion breaching the outer insulation and exposing the outer coil distal to suture tie impression.The cause of the reported event was, due to full breach outer insulation degradation and to the exposure of the outer coil in the abrasion zone consistent with friction to another device or patient anatomy.Electrical testing did not find any indication of conductor fractures or internal shorts.Further information was requested, but not received.

Event Description

Related manufacturer reference number: (b)(4).It was reported, that the patient presented with an unspecified sensing issue of the right ventricular and right atrial lead.The leads were explanted.Patient status was not known.

• Brand Name: TENDRIL ST
• Type of Device: 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: 18834660
• MDR Text Key: 336851088
• Report Number: 2017865-2024-34096
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734501705
• UDI-Public: 05414734501705
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: 1888TC/58
• Device Lot Number: 4322429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACCENT DR; MASTER'S STANDARD A ORTIC
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male