MAUDE Adverse Event Report: ABBOTT PROMOTE+ CRT-D W/SJ4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD3211-36Q
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was unable to be interrogated via inductive telemetry during an in clinic follow-up.The device was explanted and replaced to resolve the event and the patient was in stable condition.
Additional Manufacturer Narrative
The reported field event of failure to interrogate was not confirmed.Both radiofrequency and inductive telemetry were tested and revealed to be functional.Interrogation of the device revealed the device was above elective replacement indicator (eri) voltage level upon receipt.A longevity calculation was performed and revealed the battery depletion was normal based on the device usage and programmed settings.The telemetry, pacing, sensing, impedance, high voltage output, high voltage shock, and patient notifier were tested on the bench and no anomaly was detected.

• Brand Name: PROMOTE+ CRT-D W/SJ4 CONNECTOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16822839
• Report Number: 2017865-2023-18188
• Device Sequence Number: 6868009
• Product Code: NIK
• UDI-Device Identifier: 05414734503679
• UDI-Public: 05414734503679
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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
• Report Date (Section B): 07/19/2023

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: 01/31/2017
• Device Model Number: CD3211-36Q
• Device Catalogue Number: CD3211-36Q
• Device Lot Number: S000009311
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2015
• 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