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

Model Number PM3242

Device Problem Failure to Disconnect (2541)

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

Event Date 07/04/2023

Event Type  malfunction  

Event Description

During a device exchange procedure, the atrial lead was unable to be disconnected from the device header.The device header was broken open to disconnect the atrial lead.A new device was placed as anticipated.The patient was stable.

Manufacturer Narrative

The reported event of had to break the header to remove the lead was confirmed.Analysis revealed this device has the original scalable brady pacemaker (sbp) header design, which is known to have lead insertion and removal difficulties.The original sbp header required extra above normal forces to insert and to remove leads from the connector ports.

• Brand Name: ALLURE QUADRA RF 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: 17390793
• MDR Text Key: 319737727
• Report Number: 2017865-2023-36670
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: 05414734507912
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: PM3242
• Device Lot Number: 4633735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2014
• 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