Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pace

FDA device recall Z-2784-2015 · posted 2015-09-28 · Terminated

Recall details

Recalling firm

St Jude Medical Cardiac Rhythm Management Division

Reason for recall

Some devices exhibit backup VVI operation due to a backup reset.

Action taken

The notification material is in the form of a Physician Letter was delivered to physicians by FedEx overnight service. The mailing went out on August 17, 2015 for receipt on August 18, 2015. The firm's notification letter identifies clinical implications. Clinical Implications In the event that an Ellipse, Fortify Assura, Unify Assura, or Quadra Assura ICD enters the back-up safety mode, the nominal operational settings will be VVI pacing mode, 67 ppm, 5.0v/0.6ms with bipolar pacing output and defibrillation settings of aVF detection rate of 146 bpm and 36J high voltage therapy. In the event an Assurity or Allure pacemaker enters backup mode, it will have output settings of VVI pacing mode, 67 ppm, 5.0v/0.6ms with unipolar pacing. This anomaly can only occur when the patient is being actively monitored by a Merlin@home bedside transmitter. If a device enters backup mode, the ICD will deliver a patient vibratory alert and the pacemaker will deliver a patient audible alert. If backup operation is encountered, St. Jude Medical Technical Services (1-800-722-3774) can assist with non-invasively restoring the device to normal operation. The firm's notification also idenfities recommendations and mitigations. Recommendations and Mitigations Once available, a Merlin@home transmitter software update will be performed automatically over its telephone, broadband or cellular connection without requiring any action from you or your patients. No changes to the patients remote or in-clinic follow up schedules are required. In the event a patients device reverts to back-up mode, the firm recommends bringing the patient back in the clinic to clear the condition and return the device to full functionality. If you have any questions or concerns contact the local St. Jude Medical representative or St. Jude Medical's Technical Services Department.

Root cause

Software change control

Status

Terminated

Product code

NVZ

Quantity affected

259,214 transmitters (U.S. distribution) 23,604 (foreign distribution)

Distribution

Worldwide Distribution-US (nationwide) and foreign distribution to the following: Japan, France, Austria, Canada, Italy, Spain, Netherlands, South Africa, Great Britain, Australia, Sweden, Belgium, Fi

Date initiated

2015-08-18

Date posted

2015-09-28

Date terminated

2016-05-19

Location

Sylmar, CA