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

Model Number	CD3215-36Q
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No complaint was received with the return of the device.Failure event observed during analysis.Final analysis found the device to be in backup vvi.Bench testing was performed and no source of high current was identified.Stress testing was also performed and the failure was unable to be recreated.The cause of the backup vvi status was undetermined.Additionally, bench testing was performed on the right ventricular (rv) and left ventricular (lv) pace outputs because they were being sensed on the atrial channel.In-lab testing and analysis were performed and revealed no electrical shorts present between the atrial and ventricular low voltage channels.The cause of the pacing anomaly was determined to be a u1 issue.
Event or Problem Description
This report is to advise of an event observed during analysis.

• Brand Name: PROMOTE ACCEL ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10247216
• Report Number: 2938836-2020-07309
• Device Sequence Number: 2425673
• Product Code: NIK
• UDI-Device Identifier: 05414734503099
• UDI-Public: 05414734503099
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2020

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: 07/31/2012
• Device Model Number: CD3215-36Q
• Device Catalogue Number: CD3215-36Q
• Device Lot Number: 3424455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1