MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL MRI; No Match

Model Number LPA1200M/52

Device Problems Intermittent Capture (1080); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)

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

Event Date 02/29/2024

Event Type  Injury  

Event Description

It was reported that the patient underwent an unrelated procedure for ablation a month after initial implant.The patient presented in clinic following the ablation procedure.It was observed that the right atrial (ra) lead exhibited poor sensing and intermittent capture.The ra lead was found to have dislodged.The ra lead was explanted and replaced.The patient was stable before, during and after the procedure.

• Brand Name: TENDRIL MRI
• Type of Device: No Match
• 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: 18927242
• MDR Text Key: 337944310
• Report Number: 2017865-2024-35294
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734504621
• UDI-Public: 05414734504621
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P140033
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LPA1200M/52
• Device Lot Number: P000181101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2023
• 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: ASSURITY MRI PACEMAKER; TENDRIL MRI
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 77 KG