DOBELLE INSTITUTE PHRENIC NERVE PACER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-10-26 for DOBELLE INSTITUTE PHRENIC NERVE PACER manufactured by Dobel Institute, Inc..

Event Text Entries

[138398] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4002888
MDR Report Key303989
Date Received2000-10-26
Date Added to Maude2000-11-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDOBELLE INSTITUTE PHRENIC NERVE PACER
Generic NamePHRENIC NERVE PACER
Product CodeGZE
Date Received2000-10-26
Model NumberNI
Catalog NumberNI
Lot NumberNI
ID NumberNI
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagY
Date RemovedI
Device Sequence No1
Device Event Key294198
ManufacturerDOBEL INSTITUTE, INC.
Manufacturer Address61 MALL DR COMMACK NY 117255703 US


Patients

Patient NumberTreatmentOutcomeDate
10 2000-10-26

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