MAUDE Adverse Event Report: ST. JUDE ST. JUDE MERLIN TRANSMITTER; PACEMAKER DATA TRANSMITTER

Model Number EX 1150

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Weakness (2145); Diminished Pulse Pressure (2606)

Event Date 02/13/2015

Event Type  Injury  

Event Description

Pacemaker problem report (b)(6) 2015 pacemaker: st.Jude assurity pm2240 bedside transmitter: merlin, woke up (b)(6) 2015 about 4 am, and felt very weak.The discomfort continued in morning.A bp check showed an irregular heart rate, apparently due to a very low pulse.At 9:47 am my mp was 70/50/66.I knew the 66 pulse rate was below my minimum pacemaker setting.I therefore concluded that i had some sort of pacemaker problem.I made several tries to reach my electro-physiologist, but encountered busy signals.I finally got through and made an appointment for early that afternoon.Fortunately i had a driver available.In route, i was exhausted after walking 50 feet, though i usually can walk several miles on irregular terrain.I was told the incident was caused by a recently identified programming bug in the merlin transmitter.The transmitter improperly determined that the pacemaker was failing, and directed the pacemaker to fall back to a minimal action mode.I had no warning about the known bug and its potential effects.It is very peculiar that a transmitter is permitted to partially disable the pacemaker without physician review.Subsequent to my reset, there was no indication that the transmitter delivered an emergency message to a responsible physician reporting that immediate attention was necessary.There also was no mechanism to inform me of the action it had taken.My physicians had proposed a-v node ablation in the recent past.I imagine that procedure would have further complicated the adverse event.It appears that in addition to clearing the bug, procedural and hardware changes should be instituted.The merlin transmitter should have a warning light instructing the pt to contact his physician.The transmitter should connect to a qualified party for authorization, or at least send an emergency message of the action it has taken.

• Brand Name: ST. JUDE MERLIN TRANSMITTER
• Type of Device: PACEMAKER DATA TRANSMITTER
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 4540973
• MDR Text Key: 5353125
• Report Number: MW5040850
• Device Sequence Number: 1
• Product Code: DRG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: EX 1150
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 83 YR
• Patient Weight: 88