MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. TENDRIL STS; PERMANENT PACEMAKER ELECTRODE

Model Number 2088TC/52

Device Problems Failure to Capture (1081); High impedance (1291); Kinked (1339)

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

Event Date 11/30/2017

Event Type  Injury  

Event Description

During follow-up, high impedance and loss of capture was observed on the right atrial (ra) lead.The lead was explanted and replaced in order to resolve the event.During the procedure, it was noted that the distal portion of the lead was kinked.The patient's condition was stable and there were no adverse consequences.

Manufacturer Narrative

The reported events of lead dislodgement, loss of capture, high lead impedance, and the distal portion of the lead being kinked were not confirmed.As received, a complete lead was returned in one piece.Electrical testing and x-ray examination did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead revealed no kink.The full helix extension length measured within product specification.

• Brand Name: TENDRIL STS
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7142588
• MDR Text Key: 95630492
• Report Number: 2017865-2017-36553
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 2088TC/52
• Device Lot Number: P000042374
• Other Device ID Number: 05414734502887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2017
• 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 Outcome(s): Hospitalization; Required Intervention