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

Model Number	5620
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in clinic follow up, the device was unable to be interrogated.It was suspected the device had reached end of service.The patient was stable.Further information has been request but has not yet been provided.
Event or Problem Description
Additional information was received indicating the device was explanted and replaced to resolve the event.The patient was stable.
Additional Manufacturer Narrative
The field complaint of premature discharge of battery was not confirmed.The reported event of failure to interrogate was confirmed.The device was received unable to be interrogated.The device was cut open and it was determined that battery voltage was at end of life.A longevity calculation was performed and found the battery depletion was normal based on the device usage.Functional testing was performed with new battery installed, and the device was found to be normal.

• Brand Name: ZEPHYR SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15492096
• Report Number: 2017865-2022-39415
• Device Sequence Number: 1958029
• Product Code: NVZ
• UDI-Device Identifier: 05414734501606
• UDI-Public: 05414734501606
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: 5620
• Device Catalogue Number: 5620
• Device Lot Number: 3974449
• 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: 09/09/2022
• Supplement Date Received by Manufacturer: 09/28/2022; 02/20/2023
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 10/12/2022; 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown