MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD QUADRA ASSURA DR CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3367-40QC

Device Problems High impedance (1291); Decreased Sensitivity (2534); High Capture Threshold (3266)

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

Event Date 02/02/2015

Event Type  Injury  

Event Description

It was reported that post-implant, high, out of range pacing lead impedance was observed.Decreased r-wave and increased threshold were also noted.The pocket was re-opened, and connection was confirmed to be tightened.Lead was disconnected and reconnected, and all measurements were in normal range.The patient was doing fine post-procedure.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.

• Brand Name: QUADRA ASSURA DR CRT-D, DF-4 CONNECTOR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sharon mathew ; 645 almanor avenue; sunnyvale, CA 94085 ; 4085226327
• MDR Report Key: 4594874
• MDR Text Key: 21552317
• Report Number: 2938836-2015-02688
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

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: 07/31/2016
• Device Model Number: CD3367-40QC
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2014
• 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
• Patient Outcome(s): Required Intervention