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

Model Number 3213-36

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332)

Patient Problem Weakness (2145)

Event Date 06/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).No conclusion code available; the reported premature battery depletion was confirmed in the laboratory.Based on all available parameter and usage information, device longevity was found to be below the expected limits.With an external power supply attached, the device functioned normally.No high current was detected during testing and the power consumption was normal.The original battery was returned to the vendor for further evaluation and analysis could not conclusively determine a root cause for the premature battery depletion.

Event Description

It was reported that when the patient presented to clinic in emergency due to cardiac insufficiency, it was not possible to communicate with the device and a premature battery depletion was suspected due to a low battery voltage.The device was explanted and replaced.The condition of the patient was good.

Manufacturer Narrative

(b)(4).

• Brand Name: PROMOTE RF CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 5045176
• MDR Text Key: 24672310
• Report Number: 3010215456-2015-28432
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 06/16/2015

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: 06/30/2009
• Device Model Number: 3213-36
• Device Lot Number: 2909882
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2008
• 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: 74 YR