Model Number K273 |
Device Problem
Interrogation Problem (4017)
|
Patient Problems
Bradycardia (1751); Cardiac Arrest (1762)
|
Event Date 09/14/2022 |
Event Type
Injury
|
Event Description
|
It was reported that this patient presented to the emergency room (er) for a heart rate of 20 beats per minute (bpm) and went into cardiac arrest.This pacemaker could not be interrogated and had no response to a magnet due to battery depletion.A x-ray was performed to confirm device information.Subsequently, this device was explanted then replaced with a new pacemaker.No additional adverse patient effects were reported.
|
|
Event Description
|
It was reported that this patient presented to the emergency room (er) for a heart rate of 20 beats per minute (bpm) and went into cardiac arrest.This pacemaker could not be interrogated and had no response to a magnet due to battery depletion.A x-ray was performed to confirm device information.Subsequently, this device was explanted and replaced with a new pacemaker.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
Upon receipt at our post market quality assurance laboratory, analysis confirmed the clinical observation of unable to perform interrogation due to battery depletion.The device case was opened, and visual inspection revealed no irregularities.Testing found that the battery had depleted with a normal current drain.It was determined that there was a battery anomaly that resulted in a voltage was too low to support telemetry.
|
|
Search Alerts/Recalls
|