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

Model Number	PM3120
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2017865-2024-22645
• Device Sequence Number: 8165470
• Product Code: NIK
• UDI-Device Identifier: 05414734507882
• UDI-Public: 05414734507882
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TENDRIL STS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown