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

Model Number	CD3269-40Q
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that the patient presented for a generator change out procedure due to normal battery depletion.Upon interrogation, five post-paced t-wave over-sensing episodes were noted on the device.Programming changes were discussed; the physician elected to leave all settings as is and monitor the patient.The device was explanted and replaced.The patient was in stable condition.
Additional Manufacturer Narrative
The reported field event of post pace t-wave over sensing (pptwos) was confirmed by reviewing the device image.However, the pptwos events had occurred as a result of device¿s programmed settings.A longevity calculation was performed and found the battery depletion was normal up to eri based on the device usage and programmed settings.Telemetry, pacing, sensing, impedance, high voltage output, high voltage shock, and patient notifier were tested on the bench.No anomaly was detected.

• Brand Name: QUADRA ASSURA MP (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: 11117823
• Report Number: 2017865-2020-23285
• Device Sequence Number: 3595465
• Product Code: NIK
• UDI-Device Identifier: 05414734505710
• UDI-Public: 05414734505710
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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: 11/30/2014
• Device Model Number: CD3269-40Q
• Device Catalogue Number: CD3269-40Q
• Device Lot Number: 4101735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 03/07/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR