MAUDE Adverse Event Report: ABBOTT ZEPHYR XL SR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 5626

Device Problem Failure to Disconnect (2541)

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

It was reported that during a replacement procedure due to normal elective replacement indicator (eri), the set screw was unable to be loosened resulting in the lead being unable to disconnect from the device.The lead was capped and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported event of the setscrew could not be loosened to remove the lead was confirmed.Analysis revealed that calcified blood was filling the setscrew inset.The calcified blood was preventing the wrench from entering and engaging the setscrew inset to untighten the setscrew.Wrenches cannot penetrate the calcified blood.With calcified blood filling the inset all the wrench will do is strip the inset as in this case.For lab testing the calcified blood was removed out of the setscrew inset.A wrench then could be fully inserted into the inset.The setscrew could be untightened normally, and the stuck lead removed out of the connector.The blood came through a hole punched through the septum by the user of the torque wrench at time of implant.

• Brand Name: ZEPHYR XL SR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 18691757
• MDR Text Key: 335184979
• Report Number: 2017865-2024-22424
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P880086
• 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: 04/04/2024

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: 01/31/2010
• Device Model Number: 5626
• Device Lot Number: 2907253
• 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: Not provided
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2008
• 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