MAUDE Adverse Event Report: ABBOTT UNIFY ASSURA ICD; NO MATCH

Model Number CD3361-40C

Device Problem No Pacing (3268)

Patient Problem Discomfort (2330)

Event Date 11/28/2023

Event Type  Injury  

Event Description

The patient presented in the hospital feeling unwell.The device was interrogated and it was observed the device recently reached elective replacement indicator (eri) level and the device was not stimulating with therapies being disabled along with measurements being out of range.The event was resolved by explanting and replacing the device.The patient was in stable condition.

Manufacturer Narrative

The report events of pacing, impedance, and therapy anomalies were confirmed.The cause of these anomalies was due to premature battery.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.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18387524
• MDR Text Key: 331286046
• Report Number: 2017865-2023-95494
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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: 02/28/2017
• Device Model Number: CD3361-40C
• Device Lot Number: S000002410
• 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: 12/20/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2015
• 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-0116-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention