NEURX DIAPHRAGM PACING SYSTEM 20-0045

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-01 for NEURX DIAPHRAGM PACING SYSTEM 20-0045 manufactured by Synapse Biomedical Inc..

Event Text Entries

[32747818] Patient had wires protruding from the skin. Electrodes visible in open wound near sub-xyphoid exit/tunneling point. The electrode was initially tunneled near the skin surface, eventually eroded through the skin, exposing electrode underneath. Surgeon retracted the electrodes from lateral chest area to sub xiphoid region where they were trimmed and reblocked. Patient continues to use dps system.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005868392-2015-00004
MDR Report Key5266871
Date Received2015-12-01
Date of Report2015-10-27
Date of Event2015-10-01
Date Mfgr Received2015-10-01
Device Manufacturer Date2014-04-04
Date Added to Maude2015-12-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR MARK BARBUTES
Manufacturer Street300 ARTINO STREET
Manufacturer CityOBERLIN OH 44074
Manufacturer CountryUS
Manufacturer Postal44074
Manufacturer Phone4407742488
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameNEURX DIAPHRAGM PACING SYSTEM
Generic NameDIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPICALLY-IMPLANTED STIMULATOR
Product CodeOIR
Date Received2015-12-01
Model Number20-0045
Lot Number20-0045-120511-4-3
Device Expiration Date2012-03-31
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSYNAPSE BIOMEDICAL INC.
Manufacturer Address300 ARTINO STREET OBERLIN OH 44074 US 44074


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-12-01

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