MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-25 for NEUROTHERM? ADAPTOR CABLE NT GENERATOR TO DISPOSABLE DACUK-NT manufactured by Neurotherm, Inc.
[187167797]
The results of the investigation are inconclusive since the device was not returned for analysis. Device return was requested however the adaptor cable was retained by the customer. The device history record was not reviewed as the batch number was not available. Based on the information received, the cause of the reported communication issue and subsequent cancelled procedure could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[187167798]
During a radiofrequency (rf) ablation procedure a cancellation occurred due to a communication issue. Following patient prep, when rf probes were connected to the generator the indicator light remained red. Different probes and adaptors were utilized and the generator was restarted but the issue was not resolved. The procedure was cancelled. There were no adverse patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002953813-2020-00013 |
| MDR Report Key | 9880048 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-25 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| 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 | 2020-03-25 |
| 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 | 1. Other | 2020-03-25 |