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

Model Number 3207-36

Device Problem Failure to Interrogate (1332)

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

Event Date 11/13/2014

Event Type  Injury  

Manufacturer Narrative

Evaluation description: the reported inability to interrogate was confirmed in the laboratory and was due to premature battery depletion.Review of the information provided to technical services indicated that the longevity was below expected limits.The device was tested on the bench and no anomalies were found.The original battery was returned to the vendor for further evaluation and no anomaly was found.The cause of the premature battery depletion could not be determined.

Event Description

It was reported that upon interrogation, the device could not be interrogated.Patient was asymptomatic.Device was explanted and replaced.The patient was fine post procedure.

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

• Brand Name: PROMOTE RF CRT-D
• 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: 4359239
• MDR Text Key: 13076625
• Report Number: 2938836-2014-19151
• Device Sequence Number: 1
• Product Code: NIK
• 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,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: 02/28/2010
• Device Model Number: 3207-36
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/22/2015; 03/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2009
• 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: 90 YR