MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-10-27 for EON MINI 3788 manufactured by St. Jude Medical - Neuromodulation.
[4973511]
It was reported the patient is experiencing a jolting sensation for 3-4 minutes at the ipg site when stimulation is initially turned on which eventually subsides. The patient will be following up with his physician in the future.
Patient Sequence No: 1, Text Type: D, B5
[12436914]
Correction numbers: 1627487-07262012-002-r, 1627487-05242011-002-r. This ipg serial number was included in field advisories. Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Sjm defers to the patient's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1627487-2014-26884 |
| MDR Report Key | 4235958 |
| Report Source | 07 |
| Date Received | 2014-10-27 |
| Date of Report | 2014-10-03 |
| Date of Event | 2014-10-03 |
| Date Mfgr Received | 2014-10-03 |
| Device Manufacturer Date | 2010-02-01 |
| Date Added to Maude | 2014-11-10 |
| 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 | TANJA HOFFMAN |
| Manufacturer Street | 6901 PRESTON RD. |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal | 75024 |
| Manufacturer Phone | 9723098520 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1627487-12192011-003-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EON MINI |
| Generic Name | SCS IPG |
| Product Code | IPG |
| Date Received | 2014-10-27 |
| Model Number | 3788 |
| Lot Number | 3058402 |
| ID Number | 05414724402651 |
| Device Expiration Date | 2012-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL - NEUROMODULATION |
| Manufacturer Address | PLANO TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-27 |