FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2903070
·
Received January 3, 2013
Report
- Report Number
- 1627487-2013-10005
- Event Type
- Injury
- Date Received
- January 3, 2013
- Date of Event
- December 12, 2012
- Report Date
- December 13, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-10006. IT WAS REPORTED THE PHYSICIAN SUSPECTED A BROKEN SCS LEAD BASED UPON IMPEDANCE READINGS (B)(4). IN ADDITION, IT WAS REPORTED THE PT WAS NON-COMPLIANT WITH USE OF THE SCS SYSTEM. AS A RESULT OF THE AFOREMENTIONED ISSUES, THE PHYSICIAN ELECTED TO REMOVE THE ENTIRE SCS SYSTEM. PLEASE NOTE: ADD'L DEVICE INFO FOR THE IPG HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFO WAS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3419 | OCTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3183 | 3269333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |