MAUDE Adverse Event Report: ABBOTT ALLURE CRT-P; NO MATCH

Model Number PM3120

Device Problem Failure to Disconnect (2541)

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

Event Date 08/25/2023

Event Type  Injury  

Event Description

Related manufacturer report number: 2017865-2024-22646.It was reported, during an elective device replacement procedure, the right ventricular (rv) lead was unable to be removed from the device header.The procedure was stopped due to the inability to disconnect the lead and device.An additional procedure was performed and the device and rv lead were explanted and replaced to resolve the event.The patient was stable.

Manufacturer Narrative

The reported event of unable to loosen the ventricular setscrew was confirmed.Analysis revealed epoxy was found in the ventricular connector block threads, which resulted in the reported stuck setscrew event.The observed epoxy was caused by a manufacturing anomaly.

• Brand Name: ALLURE CRT-P
• Type of Device: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18711664
• MDR Text Key: 335473945
• Report Number: 2017865-2024-22645
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: PM3120
• Device Lot Number: 4764246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2014
• 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: TENDRIL STS
• Patient Outcome(s): Required Intervention