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

Model Number CD2357-40Q

Device Problems Premature Discharge of Battery (1057); Wireless Communication Problem (3283); Interrogation Problem (4017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2022

Event Type  Injury  

Manufacturer Narrative

The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.

Event Description

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

Event Description

New information received notes that the implantable cardioverter defibrillator had also exhibited a failure to be interrogated via radiofrequency.

Manufacturer Narrative

Correction: h6 medical device code previously reported as "4017 - interrogation problem" now updated to "3283 - wireless communication problem".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 october 2016.The reported field event of telemetry lockout was not confirmed.The device was interrogated on a programmer and communication using both rf and inductive telemetry was normal.

Event Description

New information received notes that the loss of radiofrequency (rf) telemetry was due to device telemetry lockout, a normal device function in which it switches from high speed telemetry to slow speed telemetry to save battery.

• Brand Name: FORTIFY ASSURA DR ICD, US
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15417639
• MDR Text Key: 299852379
• Report Number: 2017865-2022-38049
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734508094
• UDI-Public: 05414734508094
• 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
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2022

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: 03/31/2017
• Device Model Number: CD2357-40Q
• Device Catalogue Number: CD2357-40Q
• Device Lot Number: A000003277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 09/13/2022; 09/13/2022
• Supplement Dates FDA Received: 09/30/2022; 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2015
• 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-0003-2018; Z-0115-2017
• Patient Sequence Number: 1
• Treatment: DURATA ACTIVE.; TENDRIL.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 84 KG