MAUDE Adverse Event Report: ABBOTT 5356 VERITY DR, AB 20 55 184; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number	5356
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in-clinic follow-up, the device was unable to be interrogated.Abbott technical support was contacted, and the device software was upgraded, however, the device was still unable to be interrogated.Device replacement is anticipated to resolve the event.The patient was stable and will continue to be monitored.
Event or Problem Description
Additional information received indicated the device was later explanted and replaced to resolve the event.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of failure to interrogate was confirmed.The device was received with battery voltage at end of service (eos) level consistent with the interrogation anomaly reported by the field.Device image could not be saved due to low battery voltage.Electrical analysis performed, after replacing the battery, indicated normal functionality with normal interrogation results.Further evaluation at various pulse amplitude measured current level within normal range and no interrogation anomaly noted.Longevity assessment was performed based on nominal settings and the device exceeded projected longevity indicating normal battery depletion.

• Brand Name: 5356 VERITY DR, AB 20 55 184
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18284967
• Report Number: 2017865-2023-94206
• Device Sequence Number: 15120262
• Product Code: DXY
• UDI-Device Identifier: 05414734006835
• UDI-Public: 05414734006835
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 02/14/2024

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: 01/31/2009
• Device Model Number: 5356
• Device Lot Number: 2918525
• 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: 11/22/2023
• Supplement Date Received by Manufacturer: 12/11/2023; 02/05/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 12/11/2023; 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2007
• 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