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

Model Number LPA1200M/58

Device Problems Capturing Problem (2891); Device Sensing Problem (2917)

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

Event Date 03/18/2024

Event Type  Injury  

Event Description

It was reported, that the patient presented to the clinic for a follow up.Interrogation of the pulse generator noted, that the lead had high capture threshold and decreased r-wave sensing measurements.The lead was capped and replaced on (b)(6) 2024.The patient was stable throughout 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: 18956736
• MDR Text Key: 338304452
• Report Number: 2017865-2024-35614
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734504638
• UDI-Public: 05414734504638
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

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 Expiration Date: 10/31/2017
• Device Model Number: LPA1200M/58
• Device Lot Number: S000033940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2017
• 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
• Treatment: ASSURITY; TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 110 KG