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 2011-04-18 for NEURX DIAPHRAGM PACING SYSTEM 20-0035 manufactured by Synapse Biomedical Inc..
[1974710]
Per the notifying physician, (b)(6), in a letter to the implanting physician, (b)(6): the patient "was recently admitted at a local hospital in (b)(6) with a diagnosis of nephrolithiasis and left ureteral stone on (b)(6) 2011. During his hospitalization, he had an episode of ventricular fibrillation and cardiac arrest requiring cardioversion, during a bathing procedure. He was seen and evaluated by (b)(6), cardiologist, who felt this may be due to conduction of dps system. During his hospitalization, i spoke with (b)(6) and asked to have the patient discontinue the use of dps system, until we had an opportunity to evaluate the system in an electrophysiology lab. I met the patient in my office on (b)(6)2011 and scheduled him for evaluation in our ep lab with my colleague (b)(6), ep cardiologist. On (b)(6) 2011, we evaluated the patient in the ep lab and were able to reproduce episodes of v-tach while using the dps system with changes in position of the patient. "
Patient Sequence No: 1, Text Type: D, B5
[8987454]
(b)(4). The neurx dps was being used "off-label" with this patient in that the patient has a cardiac pacemaker, which is advised against in the warnings and cautions and procedure risks sections of the device labeling (surgeon instruction manual pn 77-0050 rev a). In addition, this patient's cardiac pacemaker was replaced after the neurx dps was implanted but the physician who implanted the neurx dps was not notified and the patient was not re-evaluated for cardiac interference or device to device interaction. Synapse biomedical is aware of only four incidents of apparent device-induced arrythmias in a population of approximately 400 patients with the device (b)(4). In each of the four cases, the patient had a cardiac pacemaker in place and all were managed by adjusting stimulus parameters to eliminate any detectable interference. We are aware of approximately 25 patients with the neurx dps that also have cardiac pacemakers, ten of which were implanted in a controlled arm of the (b)(4). Based on this information, we do not believe any further action is needed for patients (current or prospective) who do not have cardiac pacemakers. The product labeling already warns against implanting the device in patients with cardiac pacemakers but we believe the warnings, cautions and risks should be enhanced given the additional post-market clinical information available. Synapse biomedical will work with the (b)(4) for this device via the (b)(4) process to strengthen the labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005868392-2011-00001 |
| MDR Report Key | 2114661 |
| Report Source | 05,06,07 |
| Date Received | 2011-04-18 |
| Date of Report | 2011-04-15 |
| Date of Event | 2011-01-21 |
| Date Mfgr Received | 2011-03-15 |
| Device Manufacturer Date | 2009-08-06 |
| Date Added to Maude | 2011-06-09 |
| 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 |
| Product Code | HCC |
| Date Received | 2011-04-18 |
| Model Number | 20-0035 |
| Catalog Number | 20-0035 |
| Lot Number | 20-0035-080609-5-4 |
| Device Expiration Date | 2010-12-31 |
| 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 | 2011-04-18 |