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

Model Number	5826
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a normal device exchange procedure, multiple wrenches were used to remove the lead from the device but the wrenches were unable to engage the set-screw of the device.The silicone seal was removed and the head of the screw was cleaned to try and resolve the issue, the wrench was still unable to engage the set-screw after.The lead was then cut and capped to resolve the event.The device was explanted and a new device was implanted successfully.The patient is stable.
Additional Manufacturer Narrative
The reported event of cannot untighten the a-setscrew to remove the lead was confirmed.Analysis revealed that calcified blood was filling the a-setscrew inset, preventing the wrench from engaging enough of the inset to untighten the setscrew.Wrenches cannot penetrate calcified blood so the wrench could only be partially inserted into the setscrew inset.Since the wrench cannot engage the inset, it will slip around in the inset and strip that portion of the inset it is in contact with without untightening the setscrew.In lab testing the calcified blood was removed from the setscrew inset.A wrench could then be fully inserted to engage and untighten the setscrew.The stuck lead was then removed.The calcified blood came through a hole punched out through the septum by the user of the torque wrench at the time of implant.

• Brand Name: ZEPHYR XL DR
• 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24472309
• Report Number: 2017865-2026-02777
• Device Sequence Number: 18537212
• Product Code: NVZ
• UDI-Device Identifier: 05414734501620
• UDI-Public: (01)05414734501620(10)3575976(17)130630
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2026
• 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): 04/02/2026

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: 06/30/2013
• Device Model Number: 5826
• Device Lot Number: 3575976
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2011
• 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