MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-15 for NEUROTHERM? ADAPTOR CABLE NT GENERATOR TO DISPOSABLE DACUK-NT manufactured by Neurotherm, Inc.
[111151506]
The results of the investigation are inconclusive since the device was not returned for analysis. Review of the device history record was not possible as the lot number is unknown. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[111151507]
Related manufacturer reference number: (b)(4). During a procedure port 1 on the generator displayed an unsafe probe error message when going into lesion mode. The procedure was cancelled and there were no adverse consequences to the patient. Further troubleshooting determined the issue was due to two generator adapter cables.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002953813-2018-00036 |
| MDR Report Key | 7604827 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-15 |
| Date of Report | 2018-06-15 |
| Date of Event | 2018-05-21 |
| Date Mfgr Received | 2018-05-22 |
| Date Added to Maude | 2018-06-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DENISE JOHNSON |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517564470 |
| Manufacturer G1 | NEUROTHERM, INC |
| Manufacturer Street | 600 RESEARCH DRIVE STE 1 |
| Manufacturer City | WILMINGTON MA 01887 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01887 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROTHERM? ADAPTOR CABLE NT GENERATOR TO DISPOSABLE |
| Generic Name | MEDICAL DEVICE ELECTRICAL CABLE, REUSABLE |
| Product Code | IKD |
| Date Received | 2018-06-15 |
| Model Number | DACUK-NT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUROTHERM, INC |
| Manufacturer Address | 600 RESEARCH DRIVE STE 1 WILMINGTON MA 01887 US 01887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-15 |