FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2902993
·
Received December 26, 2012
Report
- Report Number
- 1627487-2012-16016
- Event Type
- Injury
- Date Received
- December 26, 2012
- Date of Event
- August 10, 2012
- Report Date
- August 10, 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 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 2. REF MFR REPORT # 1627487-2012-16017. IT WAS REPORTED THE PT'S LEADS WERE EXPLANTED AND REPLACED WITH A SINGLE LEAD (DIFFERENT MODEL) DUE TO INADEQUATE COVERAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST JUDE MEDICAL - NEUROMODULATION | 3186 | 3083399 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | SCS IPG: MODEL 3788| IMPLANT: |