N
Patient 1
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.
MAUDE MDR 9908944
- MDR report key
- 9908944
- Report number
- 1627487-2020-03479
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-12
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ANDREA DEITZ
- Address
- 6901 PRESTON ROAD PLANO TX 75024 US
- Phone
- 972-972-9723
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EON RECHARGEABLE IPG, 16-CHANNEL | SCS IPG | ST. JUDE MEDICAL - NEUROMODULATION | LGW | 3716 | 3716 | 119749 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. O |
Event Narratives#
D
Patient 1
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.
N
Patient 1
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.