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

Model Number 2088TC/65

Device Problems Fracture (1260); Difficult to Insert (1316); Kinked (1339)

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

Event Date 12/04/2017

Event Type  malfunction  

Event Description

It was reported that the patient presented in the procedure for an initial implant.During the procedure, it was noted that the lead was difficult to implant.The physician noted that the lead appeared to kink multiple times.Lead damage was not noted but the physician was concerned that the kink could have resulted in lead fracture.The lead was not used and replaced.The surgery continued without complication and the patient did not experience any symptoms.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

Event Description

New information available on 1/22/2018 states that, the lead was noted to be fractured.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7134541
• MDR Text Key: 95456010
• Report Number: 2017865-2017-36452
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960013
• 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,Followup,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 2088TC/65
• Device Lot Number: P000045125
• Other Device ID Number: 05414734505055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2017
• 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
• Patient Age: 79 YR