DYNATRON STS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-26 for DYNATRON STS * manufactured by *.

Event Text Entries

[21399145] Reporter used the dynatron sts machine for a few days. Reporter ended up hospitalized for over a month in agony. Dynatron stated no permanent damage. Reporter has permanent damage from sciatic nerve down. Rptr in constant pain. This machine is dangerous.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1029125
• MDR Report Key: 474918
• Date Received: 2003-07-26
• Date of Report: 2003-07-26
• Date of Event: 2001-06-27
• Date Added to Maude: 2003-08-04
• 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: 0
• 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: DYNATRON STS
• Generic Name: STIMULATOR
• Product Code: LIH
• Date Received: 2003-07-26
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 463784
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Deathisabilit	2003-07-26