EON
Report
- Report Number
- 1627487-2013-01370
- Event Type
- Injury
- Date Received
- March 29, 2013
- Date of Event
- February 25, 2013
- Report Date
- July 28, 2015
- Manufacturer
- ST JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
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.
SJM HAS LIMITED INFO 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.
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.
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.
IT WAS REPORTED THE PT IS EXPERIENCING TROUBLE CHARGING HER IPG. THE PT CONSULTED WITH HER PHYSICIAN TO DETERMINE IF HER IPG HAS FLIPPED. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE.
FOLLOW UP INFORMATION IDENTIFIED THE PATIENT'S IPG WAS REPLACED WITH A NEW ONE. THE PATIENT IS NOW RECEIVING EFFECTIVE STIMULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 131209 | EON | SCS IPG | LGW | ST JUDE MEDICAL - NEUROMODULATION | 3716 | 3240693 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention | IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2) |