FDA Adverse Event
Injury
Summary report: N
EONC CONVENTIONAL IPG
MDR report key: 2220257
·
Received August 16, 2011
Report
- Report Number
- 1627487-2011-01843
- Event Type
- Injury
- Date Received
- August 16, 2011
- Date of Event
- June 2, 2011
- Report Date
- July 21, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
THE PATIENT (UNITED KINGDOM) RECEIVED A SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS, SWELLING AND DISCOMFORT OVER THE IPG SITE. THE PHYSICIAN PLANNED TO PERFORM A REVISION PROCEDURE; HOWEVER, THE SURGERY DATE IS UNDETERMINED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EONC CONVENTIONAL IPG | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3688 | 3218907 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |