MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-01 for STIMUPLEX HNS 12 4892098 manufactured by B. Braun Melsungen Ag.
[19651857]
Stimuplex hns 12 nerve stimulator was returned to bbraun (b)(4) and sent to the manufacturer for eval (b)(4) 2011. A follow up with the facility was conducted on (b)(4) 2011. (b)(6), bio-med of user facility, stated that there was no pt injury. He also stated that the dial was turned up to its highest voltage (5 volts) when administered to the pt. He noted this will generally cause discomfort when doing so. He also stated that general practice with this device is to start at 1 to 1. 5 voltages and slowly turn it up to 5 voltages. While it does not appear at this time that there was a device malfunction, the manufacturer's investigation into this reported event is ongoing. Should the manufacturer's investigation identify any issues with the involved device, a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[19658624]
Stimuplex hns 12 nerve stimulator. As reported by user facility: hns12 unit, (b)(4) on 2 occasions, "shocked pt," last episode occurred on (b)(6) 2011. Ground pad in place attached to red end of cable, needle placed in black end of cable, when unit turned on, pt experienced a "shock. " no further details available as to location, intensity of shock. Info from (b)(6). (b)(6) states cable is in good working order.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2011-00075 |
| MDR Report Key | 2163777 |
| Report Source | 06 |
| Date Received | 2011-07-01 |
| Date of Report | 2011-06-30 |
| Date of Event | 2011-05-30 |
| Date Facility Aware | 2011-06-01 |
| Report Date | 2011-06-30 |
| Date Reported to FDA | 2011-06-30 |
| Date Reported to Mfgr | 2011-06-30 |
| Date Mfgr Received | 2011-06-01 |
| Date Added to Maude | 2011-09-14 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUERGEN HEIL |
| Manufacturer Street | CARL-BRAUN-STRASSE 1 |
| Manufacturer City | MELSUNGEN D-34212 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-34212 |
| Manufacturer Phone | 5661710 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STIMUPLEX |
| Generic Name | STIMUPLEX HNS 12 NERVE STIMULATOR |
| Product Code | BXN |
| Date Received | 2011-07-01 |
| Returned To Mfg | 2011-06-10 |
| Model Number | HNS 12 |
| Catalog Number | 4892098 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MELSUNGEN AG |
| Manufacturer Address | CARL-BRAUN-STRASSE 1 MELSUNGEN D-34212 GM D-34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-01 |