FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2940601
·
Received January 30, 2013
Report
- Report Number
- 1627487-2013-01117
- Event Type
- Injury
- Date Received
- January 30, 2013
- Date of Event
- January 10, 2013
- Report Date
- January 10, 2013
- 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
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
DEVICE 2 OF 3. REFERENCE MFR REPORT: 1627487-2013-1116, 1627487-2013-1118. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE STIMULATION ON HIS LEFT SIDE. X-RAYS WERE TAKEN AND SHOWED THE LEAD HAS MIGRATED. IT WAS ALSO REPORTED HE EXPERIENCING PAIN AT HIS IPG SITE. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40780 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3538704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |