MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PROMOTE+ CRT-D W/SJ4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD3357-40Q
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
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
It was reported that the patient presented for remote follow up via merlin.Net with the implantable cardioverter defibrillator in backup operation.The physician electively decided to replace the device since it was less than two years from the triggered elective replacement indicator.The device was explanted and replaced.The patient was not pacemaker dependent and was discharged post-procedure.
Additional Manufacturer Narrative
Previously reported serial number should have been (b)(6) rather than (b)(6) with corresponding implant, explant, expiration, and manufacturing dates the results/method and conclusion codes along with investigation results will be provided in the final report.
Additional Manufacturer Narrative
The reported field event of backup operation was confirmed.The cause of the event was due to two consecutive event queue overflow occurring within 32 seconds, which resulted in the device entering backup operation.The cause of event queue overflow was determined to be the integrated circuit (ic) in rf module.Interrogation of the device revealed the device was above the elective replacement indicator (eri) when received.The device was tested on the bench: telemetry, pacing, sensing, impedance, hv output, hv shock and patient notifier were tested on the bench.No anomaly was detected.

• Brand Name: PROMOTE+ CRT-D W/SJ4 CONNECTOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10167962
• Report Number: 2017865-2020-07835
• Device Sequence Number: 16606365
• Product Code: NIK
• UDI-Device Identifier: 05414734503679
• UDI-Public: 05414734503679
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: CD3357-40Q
• Device Catalogue Number: CD3211-36Q
• Device Lot Number: A000012578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 06/16/2020; 08/07/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/07/2020; 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 83