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

Model Number CD3231-40Q

Device Problem Delayed Charge Time (2586)

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

Event Date 11/11/2014

Event Type  Injury  

Event Description

It was reported that a merlin.Net transmission showed capacitor charge time limit was reached.The patient was brought into the clinic and two capacitor maintenances were performed; charge times were normal.Patient will continue to be monitored.

Event Description

New information received states that the device was explanted and replaced.

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

The reported extended charge time was confirmed in the laboratory via review of the device image.The device was tested on the bench and no anomaly was found.The hv capacitors were returned to the manufacturer for further analysis and an internal hv capacitor anomaly was found to be the cause of the reported extended charge time.(b)(4).

• Brand Name: UNIFY 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: 4354845
• MDR Text Key: 5202616
• Report Number: 2938836-2014-18958
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• 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,Followup

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: 12/31/2011
• Device Model Number: CD3231-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/29/2015; 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2010
• 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 Outcome(s): Required Intervention
• Patient Age: 82 YR