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 2011-07-06 for NEURX DIAPHRAGM PACING SYSTEM 20-0035 manufactured by Synapse Biomedical Inc..
[2126145]
On (b)(6) 2011, the patient experienced arrhythmia and cardiac arrest and received resuscitation measures. The patient has subsequently recovered. Due to the potential for cardiac interaction in a patient with heart problems, this event has been investigated. A report from the notifying physician, dr. (b)(6) is attached.
Patient Sequence No: 1, Text Type: D, B5
[9139964]
Based on the available information provided by the implanting surgeon and a consulting cardiologist, we are unable to determine if use of the neurx dps caused or contributed to this event. An attempt to detect any cardiac rhythm disturbance in a controlled setting was not successful in inducing sustained arrhythmias. The consulting chief medical officer of the company ((b)(6) md) has reviewed the information available and has advised that in his opinion: "either his [the patient's] cardiac changes from the pe [pulmonary embolism] had improved with less pulmonary hypertension and cardiac workload or there had never been any interaction from dp to the event of the arrhythmia, which is the more likely explanation. This patient had become a higher risk of arrhythmias because of the cardiopulmonary effects of the massive pe. When a change like this occurs, the patient has developed a new heart problem and should be evaluated at highest dp settings such as is done during the initial surgical implantation. " we conclude that either the neurx dps did not cause or contribute to the event or, if the device did contribute to the event initially, the underlying cardiac conditions that created a predisposition to induced arrhythmias resolved enough during the period between the event and the controlled evaluation that the patient was no longer susceptible to interference by the time the controlled evaluation was performed. Therefore, we can identify no corrective or preventive actions beyond the warnings, precautions, and instructions already provided to clinicians and patients.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005868392-2011-00002 |
| MDR Report Key | 2160621 |
| Report Source | 05,06,07 |
| Date Received | 2011-07-06 |
| Date of Report | 2011-07-06 |
| Date of Event | 2011-06-04 |
| Date Mfgr Received | 2011-06-07 |
| Device Manufacturer Date | 2009-07-01 |
| Date Added to Maude | 2011-07-15 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURX DIAPHRAGM PACING SYSTEM |
| Product Code | HCC |
| Date Received | 2011-07-06 |
| Model Number | 20-0035 |
| Catalog Number | 20-0035 |
| Lot Number | 20-0035-070109-1-1 |
| Device Expiration Date | 2010-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2011-07-06 |