MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. FORTIFY DR, U1.6 SJ4 ID; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD2233-40Q

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

Patient Problem Bradycardia (1751)

Event Date 07/03/2017

Event Type  Injury  

Manufacturer Narrative

The device is included in the premature battery depletion with implantable cardioverter defibrillator advisory notice issued by st.Jude medical on 11 october 2016.

Event Description

It was reported that the patient presented to the hospital due to a low underlying rhythm.The device could not be interrogated, and premature end of life with a loss of output was suspected.The device was explanted and replaced and the patient was stable.Following procedure, it was noted that the can appeared to be inflated above the battery side.

Manufacturer Narrative

Premature battery depletion was confirmed by analysis.Bench testing on the device was performed, and no sources of high current were noted.In further analysis of the battery, lithium clusters were observed, but at the time of analysis the clusters did not appear to be in a location or size that would be sufficient to cause an internal short of the battery.As a result, the cause of the premature battery depletion could not be conclusively determined.However, from these analyses, in the absence of other root causes, it is probable that the premature battery depletion was caused by a lithium cluster induced short circuit.

• Brand Name: FORTIFY DR, U1.6 SJ4 ID
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6756777
• MDR Text Key: 81492427
• Report Number: 2938836-2017-30722
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• 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: CD2233-40Q
• Device Lot Number: 3153240
• Other Device ID Number: 05414734503525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2010
• 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: 37 YR
• Patient Weight: 80