INTELECT LEGEND STIM MODEL 2S *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-13 for INTELECT LEGEND STIM MODEL 2S * manufactured by Chattanooga Group.

Event Text Entries

[523699] I purchased an electrotherapy device manufactured by the chattanooga group, which is a division of encore medical. The name of the device is the "intelect legend series stim model 2s", and it is desgined to allow physicians and therapists to treat patients using multiple electrical wave form combinations for different therapeutic applications: e. G. , reduction of swelling and inflammation, reduction of musle spasms, reduction of nerve irritation, and muscle strengthening and rehabilitation. There is an instruction manual which comes with this instrument for operating the machine in each of its four available applications or modes. This instruction manual was written by the chattanooga group and comes packaged with the machine. I purchased this unit about 6 weeks ago, and followed the instruction manual--verbatim--in applying electrotherapy on my patients. One woman was suffering from moderate to severe lower back pain following an autombile accident, and a man i was treating was having a lot of pain due to a ruptured lumbar disc. On each of these patients, for multiple sessions, i applied electrotherapy with this machine using its "interferential" wave form setting, the application designed to reduce deep tissue swelling and inflammation. It requires placement of 4 pads on the body. However, after multiple complaints from one of these patients that the electrical current wasn't issuing from all pads, i finally called up chattanooga company and found out that the instruction manual was grossly incorrect in describing the means of operating the machine for this application. The gross level of inaccuracy in this manual rendered at least 10 days of care to each of these patients worthless, and resulted in significant additional pain and suffering on each of their parts. It would be analagous to rendering the treatment ineffective, and resulting in considerable pain and suffering for people with infections. Additionally, as a physician, i lost significant credibility in the eyes of these patients, and i had to reverse their charges for these therapies administered. I spoke with the head of chattanooga's technical support department and informed him of the problems with the instruction manual, and he agreed there were clear and complete inaccuracies. I let him know that i did not desire to seek damages for myself and my patients, but that i wished instead to rectify a problem with this machine which is trusted by a very large number of my colleagues nationwide. If this machine is being used according to the manual, very many patients daily are not receiving its therapeutic benefits, and i'm sure many doctors have trusted the instruction manual when applying this common therapy. While i know it would be a lengthy process to re-write the manual immediately, i requested the company at least send a letter out to all practitioners using this machine, indicating the correct steps for application of this therapy. Althouth they aggreed to send me a letter indicating the company's committment to rectify this problem, the have not done so.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1036615
MDR Report Key752596
Date Received2005-09-13
Date of Report2005-09-13
Date of Event2005-08-08
Date Added to Maude2006-08-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameINTELECT LEGEND STIM MODEL 2S
Generic NameELECTROTHERAPY MEDICAL DEVICE
Product CodeLIH
Date Received2005-09-13
Model Number2S
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key740398
ManufacturerCHATTANOOGA GROUP
Manufacturer Address4717 ADAMS RD PO BOX 489 HIXSON TN 37343 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2005-09-13

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