The manufacturer of a pacemaker device has issued a field safety notice following a programme software anomaly that could lead to:
1. Cardiac instability during surgery when a magnet is applied.
2. Unnecessary explant due to inconsistent battery information.
The manufacturer of this pacemaker device has advised that the models concerned are the Reply and Esprit models which are being interrogated with programmer containing software version 2.24. They are manufactured by Sorin CRM. The manufacturer has advised the following action should be taken:
• Do not use a programmer with 2.24 software version.
• Ensure that the manufacturer provided the relevant medical personnel or hospital with an alternative software version, 2.26 or higher.
• Identify all patients implanted with Reply or Esprit pacemakers that have previously been interrogated with a 2.24 programmer software version.
• Arrange for the follow up of affected patients in order to interrogate for the alternative software version to correct the magnet rate within 3 months.
• Consider the need to review end of life explant decisions made following interrogation with 2.24 versions.
For patients undergoing surgery:
• Identify affected patients pre operatively
• Interrogate with the alternative software.
• Do not use a magnet in affected patients.
• If a magnet is used and the heart rate drops to 30 beats per minute remove the magnet.
• If you have received one of these pacemaker models you should immediately contact the hospital that inserted the pacemaker or your medical advisor without further delay.
If any of these issues affect you please feel free to contact Liam Moloney, Solicitor Naas at 045 898000 to find out about your rights to compensation or simply log onto our website at www.moloneysolicitors.ie
