MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2009-12-14 for NEURX DIAPHRAGM PACING SYSTEM 20-0035 manufactured by Synapse Biomedical Inc..
[1316996]
The patient was implanted with the device on (b)(6) 2009, at (b)(6) hospital. While undergoing physical therapy at nearby and affiliated shepherd center the patient experienced cardiac arrest on (b)(6) 2009. Patient was resuscitated and the device was turned off. Patient has a cardiac pacemaker that was off at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
[8504491]
A synapse biomedical representative (clinical specialist) was present for the testing conducted at the user facility on (b)(4) 2009. Risk of cardiac arrhythmia is identified in the surgeon instruction manual on page 12 (synapse part #77-0050 rev a): "there is a risk of cardiac arrhythmia being caused by the placement of the electrodes in the chest cavity. " on page 30 of the manual, clinicians are instructed to test for cardiac interference: "an ekg strip is recorded with all four electrodes active to be sure there is no capture of the cardiac rhythm. " the recommended testing was performed at the time of surgical implantation but the instructions in the manual are not sufficiently detailed to instruct the clinician to test for cardiac rhythm capture with the patient in various positions. This is a rare event and we do not believe other patients are at risk. We will revise the relevant labelling to include more detailed instructions for testing for cardiac rhythm capture and submit the change as a supplement to the hde. Additional serial #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005868392-2009-00001 |
| MDR Report Key | 1566417 |
| Report Source | 05,06,07 |
| Date Received | 2009-12-14 |
| Date of Report | 2009-12-11 |
| Date of Event | 2009-11-09 |
| Date Mfgr Received | 2009-11-12 |
| Device Manufacturer Date | 2009-09-30 |
| Date Added to Maude | 2011-04-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK BARBUTES, DIRECTOR |
| Manufacturer Street | 300 ARTINO STREET |
| Manufacturer City | OBERLIN OH 44074 |
| Manufacturer Country | US |
| Manufacturer Postal | 44074 |
| Manufacturer Phone | 4407742488 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURX DIAPHRAGM PACING SYSTEM |
| Generic Name | NONE |
| Product Code | HCC |
| Date Received | 2009-12-14 |
| Model Number | 20-0035 |
| Catalog Number | 20-0035 |
| Lot Number | 20-0035-093009-3-3 |
| Device Expiration Date | 2010-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNAPSE BIOMEDICAL INC. |
| Manufacturer Address | 300 ARTINO STREET OBERLIN OH 44074 US 44074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2009-12-14 |