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

Model Number	CD3215-36Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
This report is to advise of an event observed during analysis.Related manufacturer report number: 2938836-2017-30254.

• Brand Name: PROMOTE ACCEL ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 8510360
• Report Number: 2938836-2019-02669
• Device Sequence Number: 1650575
• Product Code: NIK
• UDI-Device Identifier: 05414734503099
• UDI-Public: 05414734503099
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/12/2019
• Patient Sequence Number: 1