FDA Adverse Event
Injury
Summary report: N
EON
MDR report key: 2831282
·
Received November 6, 2012
Report
- Report Number
- 1627487-2012-03655
- Event Type
- Injury
- Date Received
- November 6, 2012
- Date of Event
- October 15, 2012
- Report Date
- October 15, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THE PT IS NO LONGER RECEIVING STIMULATION. SUBSEQUENTLY, THE PT'S SCS IPG WILL BE REPLACED DURING THE PT'S LEAD REVISION PROCEDURE (REFER TO MFR REPORT: 1627487-2012-08213). F/U IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 3145891 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | IMPLANT DATE:| SCS LEAD: MODEL 3228 |