STIMUPLEX HNS 12 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-30 for STIMUPLEX HNS 12 * manufactured by B. Braun.

Event Text Entries

[15500470] During a sciatic nerve block, the nerve stimulator was noted to not be working. A second cord was attached to the patient and it did not work either. A third cord was then attached to the stimulator and it still did not work. Another stimucath kit was then opened and still did not work. The physician then visualized the nerve with ultrasound and determined he was touching the nerve, but still no stimulation was noted. The decision was made to abort the procedure to assure no injury occurred to the nerve. The continuity of the three cords was evaluated by the facility's biomed staff resulting in two defective cords and one cord that appeared to be intact. There was no injury to the patient noted. It should be noted that once we had tried all 3 stimuplex cords that we had with the same stimucath kit, we then tried a different stimucath kit. Also, the stimuplex nerve stimulator and the stimucath nerve block kit have been cross compatible in the past and since the problem.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1832770
• MDR Report Key: 1832770
• Date Received: 2010-08-30
• Date of Report: 2010-08-10
• Date of Event: 2010-07-21
• Report Date: 2010-08-10
• Date Reported to FDA: 2010-08-30
• Date Added to Maude: 2010-09-13
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: STIMUPLEX
• Generic Name: STIMULATOR, NERVE, BATTERY-POWERED
• Product Code: BXN
• Date Received: 2010-08-30
• Model Number: HNS 12
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: B. BRAUN
• Manufacturer Address: 901 MARCON BLVD. ALLENTOWN PA 18109 US 18109

Device Sequence Number: 2

• Brand Name: STIMUPLEX
• Generic Name: STIMULATOR, NERVE, BATTERY-POWERED
• Product Code: BXN
• Date Received: 2010-08-30
• Model Number: HNS 12
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: B. BRAUN
• Manufacturer Address: 901 MARCON BLVD. ALLENTOWN PA 18109 US 18109

Device Sequence Number: 3

• Brand Name: STIMUCATH CONTINUOUS NERVE BLOCK PROCEDURAL KIT WITH NEEDLE
• Generic Name: ANESTHESIA CONDUCTION KIT
• Product Code: CAZ
• Date Received: 2010-08-30
• Model Number: 19 GA X 60 CM
• Catalog Number: AB-05060-PK
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: TELEFLEX MEDICAL, ARROW
• Manufacturer Address: PO BOX 12600 DURHAM NC 27709 US 27709

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-08-30