MAUDE Adverse Event Report: ABBOTT ALLURE RF; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3222

Device Problem Failure to Disconnect (2541)

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

Event Date 11/08/2022

Event Type  malfunction  

Event Description

It was reported that during an unrelated procedure, the hex wrench did not disengage from the set screw resulting in the inability to re-insert the set screw into the header of the device.The device was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported event of left ventricle-setscrew stuck to the wrench was confirmed.Analysis of the device revealed that the user of the torque wrench did not align the wrench tip to go into the inset of the setscrew.The wrench was inserted with the corners of the wrench tip going into, being wedged and forced into the inset walls.This resulted in the wrench being stuck in the inset of the setscrew.The setscrew was then pulled out of the device through the septum attached to the wrench tip.This is related to the user's incorrect use of the wrench.A non-abbott torque wrench was also used which is not recommended.

• Brand Name: ALLURE RF
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: 15838232
• MDR Text Key: 306828373
• Report Number: 2017865-2022-46145
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507905
• UDI-Public: 05414734507905
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: PM3222
• Device Catalogue Number: PM3222
• Device Lot Number: P000139480
• 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: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2022
• 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