FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2861101
·
Received December 4, 2012
Report
- Report Number
- 1627487-2012-03793
- Event Type
- Injury
- Date Received
- December 4, 2012
- Date of Event
- November 12, 2012
- Report Date
- November 12, 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 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
THE PT RECEIVED 2 SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT IS SEEKING ADDITIONAL BACK COVERAGE THAT CANNOT BE PROVIDED WITH HIS CURRENT SCS LEADS. SUBSEQUENTLY, THE PT HAS BEEN SCHEDULED FOR A SCS LEAD REPLACEMENT. FOLLOW-UP IDENTIFIED THE PT'S SCS LEADS WERE REPLACED WHICH RESOLVED THE ISSUE. ADDITIONALLY, THE PT'S CS IPG WAS ELECTIVELY REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 115541 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | IMPLANT DATE:| SCS IPG: MODEL 3716 |