FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2792100
·
Received October 11, 2012
Report
- Report Number
- 1627487-2012-01845
- Event Type
- Injury
- Date Received
- October 11, 2012
- Date of Event
- August 20, 2012
- Report Date
- September 20, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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
DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-1844. IT WAS REPORTED THE PT IS EXPERIENCING PAIN AT THE IMPLANT SITE (SITE UNK). SHE IS ALSO EXPERIENCING PAIN IN HER LEGS AND SHE IS LOSING HER BALANCE. THE PT HAS NOT USED THE STIMULATION IN A MONTH. HER PHYSICIAN STATES HER ARTHRITIS IS GETTING WORSE. THE PT IS REQUESTING TO BE EVALUATED AND REPROGRAMMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3189 | 3097064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | IMPLANTED:| SCS ANCHOR: MODEL 1192 |