MAUDE Adverse Event Report: GALLANT DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDDRA500Q

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

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

Event Date 10/05/2021

Event Type  malfunction  

Event Description

It was reported that the device was found to be in bluetooth low energy (ble) telemetry lockout due to excessive ble telemetry use.Upon investigation, a rapid drop in battery voltage was observed.Premature battery depletion was suspected and believed to have been caused by a ble telemetry anomaly.No intervention was performed at this time.The patient was stable and will continue to be monitored.Further information was requested but is not yet available.

Manufacturer Narrative

Correction: upon review, the implantable cardioverter defibrillator should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.

Event Description

Additional information received indicated the battery depletion observed was believed to have been normal and unrelated to the telemetry lockout.Abbott technical support was contacted and confirmed the observed battery depletion was normal and due to a high amount of capacitor charges.

• Brand Name: GALLANT DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• MDR Report Key: 12672269
• MDR Text Key: 277628048
• Report Number: 2017865-2021-34175
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• 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
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: CDDRA500Q
• Device Catalogue Number: CDDRA500Q
• Device Lot Number: S000077687
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1