FDA Adverse Event
Injury
Summary report: N
EON
MDR report key: 2791993
·
Received October 12, 2012
Report
- Report Number
- 1627487-2012-12269
- Event Type
- Injury
- Date Received
- October 12, 2012
- Date of Event
- September 19, 2012
- Report Date
- September 19, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Removal / Correction Number
- 1627487-07262012-001-C
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. 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
DEVICE 1 OF 3. REFERENCE MFR REPORT #1627487-2012-12270, 1627487-2012-12271. IT WAS REPORTED THE PATIENT MET WITH A NEW NEUROSURGEON AND PATIENT IS REQUIRED TO REMOVE ALL IMPLANTED HARDWARE PRIOR TO ADDITIONAL SURGICAL INTERVENTION. IT WAS REPORTED THE PATIENT FELT THE STIMULATION WAS NOT HELPING THE PAIN. FOLLOW UP DETERMINED THE EXPLANT WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 3161250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention | SCS ANCHOR: MODEL 1192(2)| IMPLANT: |