MAUDE Adverse Event Report: ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI TENDRIL STS

Model Number 2088TC/58

Device Problems Under-Sensing (1661); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2012

Event Type  Injury  

Event Description

It was reported that a lead was undersensing.The lead was repositioned, but the stylet would not fully insert into the lumen of the lead.The lead was ultimately replaced.

Manufacturer Narrative

This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward.Final analysis showed that the inside inner coil was clogged with blood, which was causing stylet insertion difficulty.Electrical tests of the lead found no anomalies.

• Brand Name: TENDRIL STS
• Manufacturer (Section D): ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI; 15900 valley view ct.; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI; 15900 valley view ct.; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view ct.; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4143680
• MDR Text Key: 4913894
• Report Number: 2017865-2014-05754
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: 2088TC/58
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/08/2013
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/28/2012
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/28/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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: 80 YR