MAUDE Adverse Event Report: ABBOTT UNIFY QUADRA CRT-D, OUS MODEL, DF4COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3251-40Q

Device Problems Defective Alarm (1014); Battery Problem (2885)

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

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

Following the battery performance alert (bpa) advisory and loss of vibratory and auditory notifier, a bpa was received by the clinician and awaiting explant.Further information was requested, but not yet available.The patient was in stable condition.

Event Description

Additional information received indicated that the vibratory notifier was present and that the device was explanted and replaced resolving the event.The patient was in stable condition.

Manufacturer Narrative

Additional information: d10, h3, h6, and h9.The complaint of no patient alarm for bpa was not confirmed.The bpa was detected by the programmer, but since the device has not been upgraded by firmware, a vibratory or audible alarm for a bpa will not delivered.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.

• Brand Name: UNIFY QUADRA CRT-D, OUS MODEL, DF4COMP
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9687263
• MDR Text Key: 178376529
• Report Number: 2938836-2020-00982
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: CD3251-40Q
• Device Lot Number: S000000052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0004-2018;Z-0116-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention