MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; PERMANENT PACEMAKER ELECTRODE

Model Number 2088TC/52

Device Problems Signal Artifact/Noise (1036); Difficult to Insert (1316); Over-Sensing (1438); Device Sensing Problem (2917); High Capture Threshold (3266)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient presented in clinic for routine follow up.Upon interrogation, it was revealed that the patient's atrial lead exhibited p-wave amplitude variation, high capture threshold, and was over-sensing noise resulting in inappropriate mode switching.The physician elected to revise the lead.During the procedure, the stylet could not be inserted into the lead and the lead could not be implanted.The lead was then explanted and replaced.There were no patient consequences.

Manufacturer Narrative

Correction -d4- should have been serial number cny327579 rather than cny683711.Model number, lot number, udi and expiration date all updated for cny327579.

Manufacturer Narrative

The damage found was sustained during procedure.The failure to insert the stylet was isolated to the blood noted clogged in the inner coil at the distal region.The lead was otherwise normal.

• Brand Name: TENDRIL STS
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10642829
• MDR Text Key: 210217511
• Report Number: 2017865-2020-14951
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502887
• UDI-Public: 05414734502887
• Combination Product (y/n): N
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 2088TC/52
• Device Catalogue Number: 2088TC-52
• Device Lot Number: P000043758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention