MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-31 for EON RECHARGEABLE IPG, 16-CHANNEL 3716 manufactured by St. Jude Medical - Neuromodulation.
[186091949]
Date of event is estimated. The results/method and conclusion codes along with investigation results will be provided in the final report. During processing of this complaint, attempts were made to obtain complete patient information.
Patient Sequence No: 1, Text Type: N, H10
[186091950]
It was reported the patient was experiencing pain at the ipg site. As a result, the patient underwent surgical intervention during which the ipg was explanted and replaced to a different location.
Patient Sequence No: 1, Text Type: D, B5
[188595845]
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1627487-2020-03479 |
| MDR Report Key | 9908944 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2008-07-28 |
| Date Added to Maude | 2020-03-31 |
| 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 | ANDREA DEITZ |
| Manufacturer Street | 6901 PRESTON ROAD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal | 75024 |
| Manufacturer Phone | 9723098000 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EON RECHARGEABLE IPG, 16-CHANNEL |
| Generic Name | SCS IPG |
| Product Code | LGW |
| Date Received | 2020-03-31 |
| Model Number | 3716 |
| Catalog Number | 3716 |
| Lot Number | 119749 |
| Device Expiration Date | 2010-07-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL - NEUROMODULATION |
| Manufacturer Address | 6901 PRESTON RD PLANO TX 75024 US 75024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-31 |