FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2852300
·
Received November 27, 2012
Report
- Report Number
- 1627487-2012-03769
- Event Type
- Injury
- Date Received
- November 27, 2012
- Date of Event
- November 5, 2012
- Report Date
- November 5, 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 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
THE PATIENT RECEIVED 2 SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED DURING INTRA-OPERATIVE TESTING, THE SCS LEAD SHOWED INVALID IMPEDANCE VALUES. THE PHYSICIAN BELIEVES THE IMPEDANCE VALUES WERE DUE TO THE PRESENCE OF FLUID THAT RESULTED FROM THE PATIENT BLEEDING HEAVILY AROUND THE LEAD SITE. FOLLOW- UP IDENTIFIED THE ISSUE HAS BEEN RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3792159 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE:| SCS IPG, MODEL 3788| IMPLANT DATE: |