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

Model Number 5626

Device Problems Difficult to Remove (1528); Failure to Disconnect (2541)

Patient Problem Pneumothorax (2012)

Event Date 08/29/2022

Event Type  Injury  

Event Description

During explant, the set screw in the header could not be detached from the right ventricular (rv) lead.The rv lead and the device were explanted and replaced to resolve the event.Pneumothorax was suspected following implant but no intervention was performed to treat the pneumothorax.The patient was stable and there were no adverse consequences.

• Brand Name: ZEPHYR XL SR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15414999
• MDR Text Key: 299831173
• Report Number: 2017865-2022-37994
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734501712
• UDI-Public: 05414734501712
• 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: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2010
• Device Model Number: 5626
• Device Catalogue Number: 5626
• Device Lot Number: 2908385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2009
• 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
• Patient Outcome(s): Required Intervention