MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-03-04 for RS-OA KNEE SYSTEM manufactured by Rs Medical.
[1926684]
Pt claims use of the rs-oa knee system stimulator interfered with implanted cardiac pacemaker resulting in transient heart rate changes. Pt was using the stimulator for their initial treatment but suspended the treatment after a few minutes when heart rate changes was observed. Pt said the implanted pacemaker was affected by the knee stimulation treatment. Pt did not suffer any further effects or any injury. Pt consulted with his cardiologist, did not use the stimulator further and returned the knee stimulator system.
Patient Sequence No: 1, Text Type: D, B5
[9226976]
Rs-oa knee stimulator has been returned and met all applicable quality assurance criteria and specifications. Rs-oa operation manual contraindications specify "do not use the device if you are a cardiac demand pacemaker. " prescribing physician is (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644243-2011-00006 |
| MDR Report Key | 2018677 |
| Report Source | 04 |
| Date Received | 2011-03-04 |
| Date of Report | 2011-02-03 |
| Date of Event | 2011-12-01 |
| Date Mfgr Received | 2011-02-03 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2012-05-24 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TIMOTHY JOHNSON |
| Manufacturer Street | 14401 S.E. FIRST ST. |
| Manufacturer City | VANCOUVER WA 98684 |
| Manufacturer Country | US |
| Manufacturer Postal | 98684 |
| Manufacturer Phone | 3608234940 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RS-OA KNEE SYSTEM |
| Generic Name | TRANSCUTANEOUS KNEE NERVE/MUSCLE STIM. |
| Product Code | NYN |
| Date Received | 2011-03-04 |
| Model Number | RS-OA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RS MEDICAL |
| Manufacturer Address | VANCOUVER WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-04 |