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

Model Number 1688TC/52

Device Problems Break (1069); Fracture (1260); High impedance (1291); Therapy Delivered to Incorrect Body Area (1508); Low impedance (2285); Capturing Problem (2891)

Patient Problem Discomfort (2330)

Event Type  Injury  

Event Description

Related manufacture reference number: 2017865-2023-10400.It was reported that the patient presented to the clinic with discomfort from the right ventricular lead's extra-cardiac stimulation.Upon interrogation, it was noted that the right ventricular lead exhibited both high and low pacing impedance and high capture thresholds on all vectors.Fracture and insulation damage on the right ventricular lead was suspected.It was also noted that the left ventricular lead exhibited noise due do possible insulation damage.No interventions were performed.The patient was in stable condition.

Event Description

Additional information received noted that the right ventricular lead was explanted and replaced on (b)(6) 2023.The patient's condition was unknown.

Event Description

It was reported that the patient presented to the clinic with discomfort from the left ventricular lead's extra-cardiac stimulation.Upon interrogation, it was noted that the left ventricular lead exhibited both high and low pacing impedance and high capture thresholds on all vectors.Fracture and insulation damage on the left ventricular lead was suspected.It was also noted that the atrial lead exhibited noise due do possible insulation damage.No interventions were performed.The patient was in stable condition.Additional information received noted that the left ventricular lead was explanted and replaced on 17 mar 2023.The patient's condition was unknown.

Manufacturer Narrative

Correction: b5 - extra cardiac stimulation, impedance issue, fracture and break, capture issue, and explanted lead was the left ventricular lead instead of the right ventricular lead.Noise and insulation was suspected on the atrial lead.

• Brand Name: TENDRIL SDX LEAD
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16405953
• MDR Text Key: 309895256
• Report Number: 2017865-2023-10399
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734501859
• UDI-Public: 05414734501859
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 1688TC/52
• Device Catalogue Number: 1688TC-52
• Device Lot Number: P000003636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2015
• 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: QUADRA ASSURA.; TENDRIL LEAD.
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female