NIM NIM-2 8220100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-02-25 for NIM NIM-2 8220100 manufactured by Xomed Surgical Products.

Event Text Entries

[94367] It was reported by user facility that; "pt underwent tympanomastoidectomy procedure, during which a nerve integrity monitor was used to help prevent nerve damage. Upon awakening from anesthesia following the procedure, the pt was found to have facial paresis. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1045254-1998-00001
• MDR Report Key: 153369
• Report Source: 06
• Date Received: 1998-02-25
• Date of Event: 1998-01-07
• Date Mfgr Received: 1998-02-04
• Device Manufacturer Date: 1990-10-01
• Date Added to Maude: 1998-03-03
• 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: 0
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NIM
• Generic Name: NERVE INTEGRITY MONITOR
• Product Code: IKW
• Date Received: 1998-02-25
• Returned To Mfg: 1998-01-29
• Model Number: NIM-2
• Catalog Number: 8220100
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 149414
• Manufacturer: XOMED SURGICAL PRODUCTS
• Manufacturer Address: 6743 SOUTHPOINT DR. NORTH JACKSONVILLE FL 32216 US
• Baseline Brand Name: NIM
• Baseline Generic Name: NERVE INTEGRITY MONITOR
• Baseline Model No: NIM-2
• Baseline Catalog No: 8220100
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	1998-02-25