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

Model Number	CD3211-36Q
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a clinic follow-up, a decrease in the battery longevity was noted on the device and it was suspected that there was an overestimation of the device longevity at a previous follow-up.Technical support was contacted and the device was explanted due to normal elective replacement indicator (eri) and replaced.The patient was stable and will continue to be monitored.
Additional Manufacturer Narrative
The reported event of overestimation was confirmed.The device was above elective replacement indicator (eri) upon receipt.Longevity analysis revealed the battery depletion to be normal.The device functioned normally during analysis and no anomalies were revealed.The longevity overestimation was determined to be due to an estimation inaccuracy in the merlin programmer remaining longevity calculation.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14310572
• Report Number: 2017865-2022-09483
• Device Sequence Number: 12106594
• 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: 2022
• 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): 06/30/2022

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: 11/30/2016
• Device Model Number: CD3211-36Q
• Device Catalogue Number: CD3211-36Q
• Device Lot Number: S000007249
• 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: 04/20/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2015
• 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
• Patient Sex: Unknown