MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA (DDQP+); IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD3265-40
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Codes	Dizziness (2194); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2020
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 the patient experienced presyncope and presented remotely via merlin.Net.Upon investigation, pacing inhibition due to oversensing was noted.The oversensing appeared to be a result of myopotential oversensing.Programming changes were recommended.No other patient symptoms were reported.
Additional Manufacturer Narrative
Correction: h6-initial patient codes did not correctly reflect the reported presyncopal symptoms.
Event or Problem Description
Additional information received noted that the patient received programming changes that addressed the oversensing.The patient was stable.
Additional Manufacturer Narrative
Additional information: b5.

• Brand Name: QUADRA ASSURA (DDQP+)
• 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: 10606608
• Report Number: 2017865-2020-14519
• Device Sequence Number: 13751191
• Product Code: NIK
• UDI-Device Identifier: 05414734505666
• UDI-Public: 05414734505666
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2020

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: 05/31/2015
• Device Model Number: CD3265-40
• Device Catalogue Number: CD3265-40
• Device Lot Number: 4342580
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020; 09/30/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 09/30/2020; 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR