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

Model Number CD3211-36Q

Device Problem Difficult to Interrogate (1331)

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

Event Date 07/10/2014

Event Type  Injury  

Event Description

It was reported that the device was difficult to interrogate.The programmer was stuck in the first interrogation screen and no interrogation results could be seen.Different programmers were used in different rooms but interrogation was not successful.The device was explanted and replaced.There were no adverse consequences to the patient.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

The reported field event of a telemetry anomaly was confirmed in the laboratory and was due to backup vvi.The cause of both the backup vvi mode and telemetry anomaly was due to an anomalous component on the hybrid.

• Brand Name: PROMOTE PLUS 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: cary lawler ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184932621
• MDR Report Key: 3968144
• MDR Text Key: 4629551
• Report Number: 2938836-2014-13753
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: CD3211-36Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2012
• 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