MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-15 for SUBDERMAL NEEDLE ELECTRODES SAP320609 RLSND 122-2.5 manufactured by Rhythmlink International, Llc.
[36481703]
A needle from a neuromonitoring probe broke off intra-operatively in this patient's left lower arm requiring removal after localizing with x-ray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059405 |
| MDR Report Key | 5380560 |
| Date Received | 2016-01-15 |
| Date of Report | 2016-01-11 |
| Date of Event | 2015-11-27 |
| Date Added to Maude | 2016-01-20 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUBDERMAL NEEDLE ELECTRODES |
| Generic Name | SUBDERMAL NEEDLE ELECTRODES |
| Product Code | GXZ |
| Date Received | 2016-01-15 |
| Model Number | SAP320609 |
| Catalog Number | RLSND 122-2.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RHYTHMLINK INTERNATIONAL, LLC |
| Manufacturer Address | 1140 FIRST ST. SOUTH COLUMBIA SC 29209 US 29209 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-01-15 |