MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. FORTIFY ASSURA VR ICD_IDE_US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD1257-40Q

Device Problems Premature End-of-Life Indicator (1480); Battery Problem (2885)

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

Event Date 09/24/2017

Event Type  Injury  

Event Description

Following the battery performance alert (bpa) advisory, a bpa was received by the clinician and the device was explanted.It was also noted that the device reached elective replacement indicator (eri) and end of service on (b)(6) 2017.

Manufacturer Narrative

The event date should have been (b)(6) 2017 rather than (b)(6) 2017.

Event Description

New information notes that the patient was stable following the procedure.

Manufacturer Narrative

Premature battery depletion was confirmed by analysis.No sources of high current were noted.The cause of the premature battery depletion was consistent with li cluster formation.From these analyses, in the absence of high current draw, it is probable that the premature battery depletion was caused by a lithium cluster induced short circuit.Li clusters are a known depletion mechanism for these advisory products that has been investigated and associated with a field action in october 2016.The device is included in the premature battery depletion with implantable cardioverter defibrillator advisory notice issued by st.Jude medical on 11 october 2016.

• Brand Name: FORTIFY ASSURA VR ICD_IDE_US
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 6967031
• MDR Text Key: 89914238
• Report Number: 2938836-2017-33015
• Device Sequence Number: 1
• Product Code: NVZ
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: CD1257-40Q
• Device Lot Number: 4247671
• Other Device ID Number: 05414734505475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0115- 2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR