MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA VR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD1357-40Q

Device Problems Premature Discharge of Battery (1057); Failure to Deliver Shock/Stimulation (1133); No Device Output (1435); Battery Problem (2885); No Pacing (3268)

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Complaint, Ill-Defined (2331); Diaphoresis (2452); No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Further information was requested but not received.

Event Description

Following the battery performance alert (bpa) advisory, a bpa was received by the clinician and awaiting explant.The patient was stable.

Event Description

New information received indicated that the implantable cardioverter defibrillator was explanted and replaced on (b)(6) 2019.Premature battery depletion was suspected.Patient was stable.

Event Description

New information received indicated that on (b)(6) 2019, the device did not deliver therapy resulting in the patient's heart stopping.The patient was revived.

Event Description

New information received indicated that in (b)(6) 2019 the patient had symptoms of feeling faint and alleged that their heart was not working.The patient was seen in the emergency room on (b)(6) 2019 and the physician found no issues with the patient's arteries.The patient's prescription was changed and was symptom free after the event.

Event Description

New information received indicated that the patient had presented with chest.It was noted that the patient had not received any defibrillations.The patient was in a wide-complex tachycardia and their initial blood pressure was hypotensive.The patient was also noted to be diaphoretic and ill-appearing.The patient was given medication and was given emergent electrical synchronized cardioversion.The patient was converted, and vitals improved.

Manufacturer Narrative

Premature battery depletion was confirmed by analysis.A device evaluation was performed, and 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 (b)(6)2016.

Manufacturer Narrative

Correction - h6 - previously reported code 1435 - no device output should have been 1133 - failure to deliver shock and 3268 - no pacing.

• Brand Name: FORTIFY ASSURA VR ICD, US
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8656676
• MDR Text Key: 146636900
• Report Number: 2017865-2019-08580
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734507974
• UDI-Public: 05414734507974
• Combination Product (y/n): N
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: CD1357-40Q
• Device Catalogue Number: CD1357-40Q
• Device Lot Number: 4574441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0003-2018;Z-0115-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 93