REHABILICARE IF II *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-16 for REHABILICARE IF II * manufactured by Rehabilicare.

Event Text Entries

[21964425] I was approached by a sales rep of rehabilicare- a division of complex technologies-concerning the use of their product if ii interfrential stimulator system for the use of managing chronic pain during one of my rehabilitation appointments. The sales rep indicated that all i needed was a physician order and my insurance information to begin using this product. A few weeks later, the sales representative inidcated that my insurance would fully cover this device. I spoke with physician who wrote the prescription for the device. I used it for approximately 3 months with no significant reduction of symptoms. Rehabilicare indicated through the sales team and written information i received that they would submit all documentation required by my insurance carrier. At this time i was covered under two insurance carriers. I received a letter from rehabilicare indicating that my insurance carrier rejected my claim and that i was responsible for payment. At this time i called my primary insurance carrier who indicated that they rejected the claim because this device is an experimental medical device with no proven efficacy. I was never informed of that fact by rehabilicare, or that my insurance might not cover this device. My primary insurance also indicated that they requested more information from rehabilicare regarding my treatment and the need for this device, which was never provided to them. If this information would have been provided, the device would have most likely been covered. After my first bill from rehabilicare i called accounts receivable at rehabilicare and asked what my secondary insurance carrier responded to this claim. They indicated that my secondary insurance was never billed. I then asked if they would submit a claim, and they indicated that it was too late to submit this claim. Because of misinformation concerning the approved use of this device and the poor billing practices in which i was not notified of an issue with my insurance claim, i'm now being billed over two thousand dollars. I feel that i was misled in the use of this device, its claims, and the manner this company gets reimbursed for its product. Now i'm being billed for private pay, and rehabilicare will be reimbursed the maximum payment for their device.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1040188
• MDR Report Key: 756587
• Date Received: 2005-10-16
• Date of Report: 2005-10-16
• Date of Event: 2003-12-16
• Date Added to Maude: 2006-09-05
• 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: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: REHABILICARE
• Generic Name: INTERFERENTIAL STIMULATION
• Product Code: LIH
• Date Received: 2005-10-16
• Model Number: IF II
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 744481
• Manufacturer: REHABILICARE
• Manufacturer Address: 701 US HIGHWAY 301 SOUTH TAMPA FL 33619 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2005-10-16