NI *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-17 for NI * manufactured by Ni.

Event Text Entries

[375904] The adverse event which caused partial disability and also required medical intervention (and ongoing) is a procedure called percutaneous laser disc decompression (pldd). The pldd procedure uses a yag laser as the source of heat energy used to decompress a vertebral disc. Two years later, this procedure has left pt partially disabled and financially broke due to continued medical intervention. This pldd procedure is done on an outpatient basis. Pt had three levels of vertebral discs decompressed by this instrument, yag laser. The surgery (procedure), during and after, was extremely painful to say the least. The yag laser device, used to superheat the vertebral disc, caused the following new post surgery symptoms: soreness and achiness in groin, inner leg and thigh, inflammation; walking and standing is painful; pain down to left knee; streaks of numbness throughout leg; achiness throughout buttocks and lower legs, both calves; severe loss of muscle mass, both legs; libido is poor and severe inflammation in hip, loose snapping hip. Please stop/ban this pldd procedure, before it disables more back pain sufferers such as pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033803
• MDR Report Key: 559557
• Date Received: 2004-11-17
• Date of Report: 2004-11-10
• Date of Event: 2003-01-21
• Date Added to Maude: 2004-12-15
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NI
• Generic Name: YAG LASER
• Product Code: LKW
• Date Received: 2004-11-17
• Model Number: NI
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 549260
• Manufacturer: NI
• Manufacturer Address: NI NI *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention; 2. Deathisabilit	2004-11-17