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

Model Number	CD3211-36Q
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
During an in-clinic follow up, episodes of t-wave oversensing were noted on the device.Technical support was contacted and the device was reprogrammed to resolve the event.The patient was stable with no consequences.

• Brand Name: PROMOTE+ CRT-D W/SJ4 CONNECTOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9638886
• Report Number: 2938836-2020-00655
• Device Sequence Number: 10867238
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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: 04/30/2016
• Device Model Number: CD3211-36Q
• Device Catalogue Number: CD3211-36Q
• Device Lot Number: 4861008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1