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

Model Number	5626
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2017865-2024-22424
• Device Sequence Number: 17925785
• Product Code: NVZ
• UDI-Device Identifier: 05414734501712
• UDI-Public: 05414734501712
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2008
• 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
• Patient Sex: Unknown