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

Model Number 1688TC/46

Device Problem High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2022

Event Type  Injury  

Event Description

It was reported that the patient presented for an implant procedure.Prior to the procedure, it was noted that the atrial lead exhibited high pacing impedance.The atrial lead was capped and replaced (b)(6) 2022.There were no patient consequences.

Event Description

It was reported that the patient presented for an implant procedure.Prior to the procedure, it was noted that the atrial lead exhibited high pacing impedance.The atrial lead was capped and replaced (b)(6) 2022.There were no patient consequences.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13585487
• MDR Text Key: 286007903
• Report Number: 2017865-2022-03774
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734501989
• UDI-Public: 05414734501989
• 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: Physician
• Type of Report: Initial
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Model Number: 1688TC/46
• Device Catalogue Number: 1688TC-46
• Device Lot Number: 3106786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2010
• 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: ACCENT DR RF PACEMAKER; TENDRIL SDX LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 45 KG