MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3371-40C

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2017

Event Type  malfunction  

Event Description

During lead replacement, blood entered the lead port in the device.The physician decided to explant the device and replace it.The patient was in stable condition.

Manufacturer Narrative

The contamination of the header could not be confirmed as inspection revealed no fluid in the header.Interrogation of the device revealed the device was above the elective replacement indicator when received.Pacing, sensing, impedance, high voltage (hv) output, and the patient notifier were tested and no anomaly was detected.The cause of the field event remains undetermined.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 6945539
• MDR Text Key: 89597396
• Report Number: 2938836-2017-32776
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: CD3371-40C
• Device Lot Number: P000019170
• Other Device ID Number: 05414734508384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1