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

Model Number 3207-36

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); No Device Output (1435)

Patient Problems Bradycardia (1751); Complaint, Ill-Defined (2331)

Event Date 04/28/2014

Event Type  Injury  

Event Description

It was reported that the patient called the clinic stating she had felt poorly for 3-5 days.The clinic requested a merlin net transmission, but the patient was unable to initiate one.When the patient was brought to the clinic, telemetry could not be established with the device.Ecg revealed that the patient was in bradycardia.The patient was instructed to go to the hospital for immediate device change-out.Premature battery depletion was suspected.The device exhibited no output or telemetry and was in backup mode.The device was explanted and replaced with no complications.Patient was discharged the same day.

Manufacturer Narrative

The reported field event of an inability to communicate with the device was found to be caused by low battery voltage.The low battery voltage was due to premature battery depletion.Based on the available parameter and usage information a longevity calculation was performed and was found to be below the expected limits.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.

• 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: cary lawler ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184932621
• MDR Report Key: 3892686
• MDR Text Key: 4673558
• Report Number: 2938836-2014-12322
• 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

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: 03/31/2010
• Device Model Number: 3207-36
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2009
• 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: 67 YR