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

Model Number	5826
Medical Device Problem Codes	Failure to Disconnect (2541); Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine device exchange, the ventricular lead was not able to be removed from the header of the device.A white substance was visually observed on the set screw.The ventricular lead was broken and was removed from the header of the device.The device was explanted and replaced to resolve this event.The patient was stable.
Additional Manufacturer Narrative
The reported event of cannot untighten the ventricular (v-) setscrew to remove the lead was confirmed.Analysis revealed that calcified blood was filling the (v-) setscrew inset, preventing the wrench from engaging it.Wrenches cannot penetrate calcified blood so the wrench can 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.The wrench could then fully insert and engage the inset to untighten and tighten the setscrew normally.The blood came through a hole punched out through the septum by the user of the torque wrench at 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: 23526132
• Report Number: 2017865-2025-1004582
• Device Sequence Number: 13046601
• Product Code: NVZ
• UDI-Device Identifier: 05414734501620
• UDI-Public: (01)05414734501620(10)3298752(17)120731
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2025
• 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): 01/19/2026

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: 07/31/2012
• Device Model Number: 5826
• Device Lot Number: 3298752
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2011
• 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