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

Model Number	CD3269-40
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/24/2019
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.Further information was requested but not received.
Event or Problem Description
It was reported that when the patient presented in clinic for a follow up, non-sustained rv oversensing episodes due to myopotential oversensing were observed.Programming changes were suggested.
Additional Manufacturer Narrative
Additional information: b1, b2, b5, d7, d10, g4, h1, h2, h3, h6, h10.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
New information received notes the patient's implantable cardioverter defibrillator was explanted on (b)(6) 2020.
Additional Manufacturer Narrative
Analysis was normal.No anomalies were found.

• Brand Name: QUADRA ASSURA MP (DDQP+)
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9660856
• Report Number: 2938836-2020-00819
• Device Sequence Number: 16836298
• Product Code: NIK
• UDI-Device Identifier: 05414734505703
• UDI-Public: 05414734505703
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2021

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: 11/30/2014
• Device Model Number: CD3269-40
• Device Catalogue Number: CD3269-40
• Device Lot Number: 4107163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 09/10/2020; 01/20/2021
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 09/18/2020; 01/20/2021
• 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