MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,99 report with the FDA on 2014-09-04 for EON MINI 3788 manufactured by St. Jude Medical - Neuromodulation.
[4719828]
Device 1 of 2. Reference mfr report: 1627487-2014-06258. Information provided by the patient's attorney, indicated the patient alleges she experienced overheating and burning at the implant site. Per a legal preservation notice, this patient was explanted (b)(6) 2014. Additional information is needed to clarify the nature of the patient's issues. Sjm was made aware of the issues on (b)(6) 2014, and the patient's scs system was not evaluated by an sjm representative to verify and/or troubleshoot any of the reported issues prior to explant. On (b)(6) 2012 st. Jude medical, neuromodulation division, sent field action letters to patients related to heating while charging and raised awareness of this issue to patients. An increase in prior non-reported heating while charging events and other non-reported events was expected.
Patient Sequence No: 1, Text Type: D, B5
[5714956]
Device 1 of 2. Reference mfr report: 1627487-2014-06258. Additional information received identified the patient's scs system was removed on (b)(6)2014. Review of the patient's medical record identified the patient underwent explant to obtain mri to further diagnose patients chronic low back pain and consider other treatment options.
Patient Sequence No: 1, Text Type: D, B5
[12313553]
(b)(4). This ipg serial number was included in a field advisory and a field correction. 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
[13237436]
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 | 1627487-2014-06257 |
| MDR Report Key | 4093590 |
| Report Source | 07,99 |
| Date Received | 2014-09-04 |
| Date of Report | 2015-03-19 |
| Date of Event | 2014-03-01 |
| Date Mfgr Received | 2015-03-19 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2014-09-17 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIMBERLY GOODE |
| Manufacturer Street | 6901 PRESTON ROAD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal | 75024 |
| Manufacturer Phone | 9723098541 |
| Manufacturer G1 | ST. JUDE MEDICAL - NEUROMODULATION |
| Manufacturer Street | 6901 PRESTON RD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 1627487-07262012-001-C; |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EON MINI |
| Generic Name | SCS IPG |
| Product Code | GZP |
| Date Received | 2014-09-04 |
| Model Number | 3788 |
| Lot Number | 2929926 |
| Device Expiration Date | 2012-01-01 |
| 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 | 2014-09-04 |