MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; NO MATCH

Model Number 2088TC/52

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the right atrial lead was explanted and replaced for an unknown reason.Patient status was not known.

Manufacturer Narrative

The sterilization records were reviewed, and no evidence of abnormal sterilization cycle was found.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Further information was requested but not received.

Event Description

Related manufacturer reference number: 2017865-2024-03214, related manufacturer reference number: 2017865-2024-03216, related manufacturer reference number: 2017865-2024-03218.New information received noted that the patient presented in the emergency room for an unrelated issue.During device interrogation, it was noted that the right atrial lead was dislodged which is suspected to be due to the patient's size and physical activity.When the pocket was opened for revision, there was a purulent drainage.The right atrial lead was explanted and replaced.The pacemaker, right ventricular and left ventricular lead remains implanted.The patient was in stable condition.

• Brand Name: TENDRIL STS
• 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: 18452248
• MDR Text Key: 332251983
• Report Number: 2017865-2024-00462
• Device Sequence Number: 1
• Product Code: NVN
• 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,Followup
• Report Date: 01/30/2024

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: 2088TC/52
• Device Lot Number: P000178290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2023
• 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: GALLANT HF; OPTISURE MRI; QUARTET
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female