MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) PROMOTE ACCEL ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD3215-36Q
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2018
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
It was reported that when patient presented to the clinic for a regular device check, upon device interrogation sensing noise issue was observed on the device, thirteen inappropriate auto mode switch episodes due to lead noise issue was observed on the ra lead and sensing noise issue was observed on the rv lead.Programming changes were made to minimize the occurrence of this event.The cause of the noise issue was not able to be identified.Isometric, deep breathing and pocket stimulation tests were performed however noise was not reproduced.Physician suspected atrial lead integrity issue to be correlated to the lead noise and possible atrial lead damage issue was suspected due to lead noise.No further testing was performed.It was recommended to replace the lead and that the device is reaching elective replacement indicator on (b)(6) 2018.Physician elected to monitor the lead since impedance and values are normal.Patient was stable prior and post event.

• Brand Name: PROMOTE ACCEL ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 7675223
• Report Number: 2938836-2018-08464
• Device Sequence Number: 1369600
• Product Code: NIK
• UDI-Device Identifier: 05414734503099
• UDI-Public: 05414734503099
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2018

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: 08/31/2012
• Device Model Number: CD3215-36Q
• Device Catalogue Number: CD3215-36Q
• Device Lot Number: 3377152
• 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: 06/12/2018
• Initial Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1