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

Model Number 1888TC/52

Device Problems Failure to Capture (1081); Sensing Intermittently (1558); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

It was reported that the patient was brought into the ep lab for an ep study to see if they were inducible into vt to be upgraded.Prior to the study an interrogation was performed, and it was discovered that there was no capture, and the p-waves were less than 2.The lead was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported event of failure to capture and p-wave amp variation were not confirmed.As received, a complete lead was returned in two pieces with the helix found extended/stretched and clogged with blood/tissue.Electrical testing did not find any indication of conductor fractures.Electrical testing found shorting between conductors consistent with procedural damage.Visual and x-ray inspections of the lead did not find any anomalies except for procedural damage.

• 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: 18804327
• MDR Text Key: 336507703
• Report Number: 2017865-2024-33726
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734501750
• UDI-Public: 05414734501750
• 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: Other
• Type of Report: Initial,Followup
• 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: 06/30/2012
• Device Model Number: 1888TC/52
• Device Lot Number: 2817720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2009
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 84 KG