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

Model Number CD3215-36Q

Device Problems False Alarm (1013); Low impedance (2285)

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

Event Date 07/15/2014

Event Type  malfunction  

Event Description

New information received notes that a merlin.Net transmission and alert revealed low out of range high voltage lead impedance.The hvli trend showed a low impedance value for the lower limit, but the trend did not display any out of range measurements.Device will continue to be monitored via merlin.Net.

Event Description

It was reported that the patient received an alert for hvli out of range.No out of range values appeared on the visual trend.It was suspected that the alert was false due to interference during the hvli check.Programming changes were recommended.There were no adverse consequences and the patient was fine after the event.

Manufacturer Narrative

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

• Brand Name: PROMOTE ACCEL 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: 4021833
• MDR Text Key: 5149824
• Report Number: 2938836-2014-14415
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2011
• Device Model Number: CD3215-36Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 08/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2010
• 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