DOBELLE INSTITUTE PHRENIC NERVE PACER
Received Oct 26, 2000
Report MW4002888 · MDR key 303989
Device
Generic name
Phrenic Nerve Pacer
Manufacturer
Dobel Institute, Inc.Model number
NICatalog number
NI
Lot number
NI
Product problems
- Explanted
- No Device Output
- Inadequate Service
Patient
NO INFO
- Surgical procedure, repeated
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
COMPLICATION OF THE PHRENIC NERVE PACER AS PROVIDED BY THE DOBELLE INSTITUTE. A BOARD-CERTIFIED OTOLARYNGOLOGIST INSERTED THE PHRENIC NERVE PACING WIRES WITHOUT INCIDENT IN A PT WITH NOCTURNAL HYPOVENTILATION. BOTH DIAPHRAGMS SUCCESSFULLY PACED AT APPROXIMATELY FOUR WEEKS POST-INSERTION. UNFORTUNATELY, APPROXIMATELY FOUR WEEKS LATER THE RIGHT PHRENIC NERVE HAD COMPLETELY STOPPED WORKING TO STIMULATION AND TO SPONTANEOUS VENTILATION. THIS REQUIRED THAT THE PACING WIRE BE REMOVED. AT THE TIME OF THE REMOVAL OF THE RIGHT PHRENIC NERVE PACING WIRE FROM ITS ATTACHMENT TO THE PHRENIC NERVE, THERE WAS NO APPARENT DAMAGE OR INFLAMMATION AT THE SITE OF THE PHRENIC NERVE. TO DATE THERE HAS BEEN NO RECOVERY IN THE RIGHT PHRENIC NERVE WITH CONSEQUENT MILD PARADOXICAL MOTION. THIS IS A DISASTROUS EVOLUTION IN A PT WITH CENTRAL HYPOVENTILATION SYNDROME WHO ONLY REQUIRED THE PHRENIC NERVE PACERS AT NIGHTTIME. RPTR IS UNCERTAIN AS TO WHAT TO DO ABOUT PACING THE OTHER STILL-NORMAL PHRENIC NERVE AND HAVE RECEIVED LITTLE OR NO INSTRUCTIONS FROM THE DOBELLE INSTITUTE IN THAT REGARD.