MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-02 for EON NEUROSTIMULATION SYSTEM CHARGER 3701 manufactured by St. Jude Medical.
[59239830]
A nurse is reporting on behalf of a patient, who has been using a st. Jude eon charger and sustained a 2nd degree burn on her skin. Per the reporter the charger has been recalled in 2013, however the manufacturer is still giving it out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065795 |
| MDR Report Key | 6078436 |
| Date Received | 2016-11-02 |
| Date Added to Maude | 2016-11-04 |
| 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 |
| 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 | EON NEUROSTIMULATION SYSTEM CHARGER |
| Generic Name | SPINAL CORD STIMULATOR CHARGER |
| Product Code | NHI |
| Date Received | 2016-11-02 |
| Model Number | 3701 |
| Lot Number | 3628403 |
| Device Expiration Date | 2017-02-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-02 |