MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD FORTIFY DR, DF4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD2231-40Q

Device Problems Difficult to Interrogate (1331); Pacing Problem (1439)

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

Event Date 01/23/2014

Event Type  malfunction  

Event Description

It was reported that a patient presented in the hospital for biv upgrade, dft testing and av ablation.During the av ablation procedure, communication was lost and the device had to be re-interrogated using an inductive wand since no rf communication could be established.It was also observed that device was not able to pace properly, despite being programmed at high pacing output values.The biv upgrade was abandoned as the physician was unable to locate any branches of the coronary sinus.The device was eventually able to pace successfully, but was explanted and replaced successfully.The patient was stable after the procedure and was discharged.

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

The reported field event of output anomaly was not confirmed in the laboratory.The device was tested on the bench as well as using automated test equipment and no anomalies were found.

• Brand Name: FORTIFY DR, DF4 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: cary lawler ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184932621
• MDR Report Key: 3665665
• MDR Text Key: 4347410
• Report Number: 2938836-2014-07964
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Model Number: CD2231-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/23/2014
• Device Age: 37 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2010
• 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 Age: 52 YR