NEURX DIAPHRAGM PACING SYSTEM 20-0035

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-05-03 for NEURX DIAPHRAGM PACING SYSTEM 20-0035 manufactured by Synapse Biomedical Inc..

Event Text Entries

[44332958] The device associated with this event was sent directly from the user facility to a certified, independent laboratory ((b)(6)) for testing. The testing was performed in accordance with a protocol provided by synapse biomedical inc. The protocol and summary of the results obtained are provided. The final report has not been completed but will be submitted in a follow-up report, which will contain details for each test conducted. Synapse biomedical inc. Has no further details regarding the adverse event other than those presented in the user facility report. We have had no contact with the patient's family or anyone else directly involved and it should be noted that the patient was not at the user facility at the time of the incident. The only mechanism for device shutdown is a mechanical switch that requires two buttons on the front of the device to be pressed simultaneously. The returned device was found to operate within specifications and the events described in the user facility report could not be reproduced. Manufacture and test records indicate the device was assembled according to controlled, predefined procedures and all testing met specification. There were no errors or deviations found in the device history record nor any indication that the device was defective in any way. A final conclusion will be included with the follow-up report but at this time we have identified no defects with the device, it performs within specifications and we have not be able to reproduce the adverse event as described in the user facility report.
Patient Sequence No: 1, Text Type: N, H10


[44332959] The patient was implanted with the synapse biomedical diaphragm pacing system (dps) device (b)(6) 2015. The implanting surgeon contacted a synapse biomedical representative on (b)(6) 2016 reporting that the patient had died. He stated that the mother of the patient had left the patient alone while using the dps and off the mechanical ventilator. When she came back the patient was not breathing and the dps was off. Additional information can be found in user facility report number (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005868392-2016-00001
MDR Report Key5628922
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2016-05-03
Date of Report2016-03-02
Date Mfgr Received2016-02-03
Device Manufacturer Date2015-10-28
Date Added to Maude2016-05-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMARK BARBUTES
Manufacturer Street300 ARTINO STREET
Manufacturer CityOBERLIN OH 44074
Manufacturer CountryUS
Manufacturer Postal44074
Manufacturer Phone4407742488
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEURX DIAPHRAGM PACING SYSTEM
Generic NameDIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPICALLY-IMPLANTED STIMULATOR
Product CodeOIR
Date Received2016-05-03
Returned To Mfg2016-02-16
Model Number20-0035
Lot Number20-0035-102815-3-2
Device Expiration Date2016-04-30
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSYNAPSE BIOMEDICAL INC.
Manufacturer Address300 ARTINO STREET OBERLIN OH 44074 US 44074


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2016-05-03

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