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

Model Number LPA1200M/46

Device Problem Connection Problem (2900)

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

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

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 for device upgrade procedure.During the procedure, after loosening the set screws and applying traction to the grip zone, the atrial and right ventricular leads could not be removed from the chronic pacemaker header.After several attempts, the physician was able to remove the set screws from the header of atrial and ventricular ports.It was noted that there was a very slight angulation of the terminal pin of the ventricular lead, testing of the leads revealed that there was no physical or electrical damage.The leads were inserted into the header of the new device.After placement and securing the set screws the physician loosened the set screws and attempted to remove the leads from the new device and noted that the fit was somewhat tight.A small amount of silicone lubricant was applied to each lead and they were reinserted into the new device and all tests through the new device showed the leads to be functioning appropriately.The patient was stable.

• Brand Name: TENDRIL MRI
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8275482
• MDR Text Key: 134024821
• Report Number: 2017865-2019-01181
• Device Sequence Number: 1
• Product Code: DXY
• UDI-Device Identifier: 05414734504683
• UDI-Public: 05414734504683
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: LPA1200M/46
• Device Lot Number: A000040388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2017
• 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: LPA1200M/52, (B)(4); PM2272, 7935679