MAUDE Adverse Event Report: ABBOTT PROMOTE ACCEL ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3215-36Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

Failure event observed during analysis.As received, the device was returned for analysis.During functional testing of the device, biphasic output was not observed on the oscilloscope.Further testing was performed, and reveled a transformer was loose.The cause of the output anomaly was determined to be a low gate voltage caused by a loose transformer.The cause of the loose connection is unknown.

Event Description

This report is to advise of an event observed during analysis.Related manufacturer report number: 2938836-2017-30254.

• Brand Name: PROMOTE ACCEL ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8510360
• MDR Text Key: 141797118
• Report Number: 2938836-2019-02669
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503099
• UDI-Public: 05414734503099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2011
• Device Model Number: CD3215-36Q
• Device Catalogue Number: CD3215-36Q
• Device Lot Number: 2919701
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1