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

Model Number CD3369-40Q

Device Problem Premature Discharge of Battery (1057)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the implantable cardioverter-defibrillator (icd) was noted with a battery depletion failure.The device was explanted and replaced.The patient was stable.

Manufacturer Narrative

Interrogation of the device revealed the device was at eri when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.Functional test found the device to be normal.Based on this information, there was no evidence of premature depletion.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11103155
• MDR Text Key: 224745375
• Report Number: 2017865-2020-25342
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508377
• UDI-Public: 05414734508377
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000020551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 136