|
Model Number 3650 |
Device Problems
Failure to Interrogate (1332); Application Program Freezes, Becomes Nonfunctional (4031); Program or Algorithm Execution Failure (4036)
|
Patient Problem
Arrhythmia (1721)
|
Event Date 07/26/2022 |
Event Type
Injury
|
Event Description
|
Related manufacturer reference number: 2017865-2022-17140; related manufacturer reference number: 2017865-2022-17142.It was reported a patient presented with noise on their atrial lead.This was addressed by a procedure on (b)(6) 2022 where the atrial lead was explanted and replaced.During procedure, it was noted that the right ventricular (rv) lead had silicone damage so the rv lead was explanted and replaced as well.Post-procedure, during capture threshold testing, the user released the button on the merlin programmer to terminate the testing as expected.However, the device continued to decrement, resulting in loss of capture, application program freeze, and no telemetry.The patient experienced cardiac arrest, which was resolved by cardiac massage.After this episode, the patient was stable.
|
|
Manufacturer Narrative
|
A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.
|
|
Manufacturer Narrative
|
Correction: related manufacturer reference number in b5.
|
|
Event Description
|
Related manufacturer reference number: 2017865-2022-17140 related manufacturer reference number: 2017865-2022-17146 it was reported a patient presented with noise on their atrial lead.This was addressed by a procedure on (b)(6) 2022 where the atrial lead was explanted and replaced.During procedure, it was noted that the right ventricular (rv) lead had silicone damage so the rv lead was explanted and replaced as well.Post-procedure, during capture threshold testing, the user released the button on the merlin programmer to terminate the testing as expected.However, the device continued to decrement, resulting in loss of capture, application program freeze, and no telemetry.The patient experienced cardiac arrest, which was resolved by cardiac massage.After this episode, the patient was stable.
|
|
Manufacturer Narrative
|
The reported event of the merlin programmer freezing during use was not able to be confirmed.The results of the software analysis are inconclusive since no additional information was obtained to investigate.Based on the information received, the cause of the reported incident could not be conclusively determined.
|
|
Search Alerts/Recalls
|
|
|