MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-02 for SYNAPSE BIOMEDICAL NEURX DIAPHRAGM PACING SYSTEM 20-0035 manufactured by Synapse Biomedical Inc..
[61350690]
The patient was experiencing recurring infections at the percutaneous exit site of the lead wires of the diaphragm pacing system. The caregiver for the patient was instructed on proper exit site care but the infection did not clear with this intervention. A course of antibiotic treatment cleared the infection but infection recurred when the antibiotic treatment ended. The attending physician decided to explant the electrodes and debride the area, which took place on (b)(6) 2016. Recovery was normal following the explant and the patient may be reimplanted at a later date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005868392-2016-00003 |
| MDR Report Key | 6142010 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-02 |
| Date of Report | 2016-12-01 |
| Date of Event | 2016-11-01 |
| Date Mfgr Received | 2016-11-01 |
| Device Manufacturer Date | 2015-10-28 |
| Date Added to Maude | 2016-12-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARK BARBUTES |
| 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 | SYNAPSE BIOMEDICAL NEURX DIAPHRAGM PACING SYSTEM |
| Generic Name | DIAPHRAGM PACER |
| Product Code | OIR |
| Date Received | 2016-12-02 |
| Model Number | 20-0035 |
| Lot Number | 20-0035-102815-3-3 |
| Device Expiration Date | 2016-04-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2016-12-02 |