FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 3110852
·
Received May 8, 2013
Report
- Report Number
- 1627487-2013-05651
- Event Type
- Injury
- Date Received
- May 8, 2013
- Date of Event
- April 15, 2013
- Report Date
- April 15, 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 1 OF 2. REFERENCE MFR. REPORT#: 1627487-2013-05652. IT WAS REPORTED THE PATIENT IS EXPERIENCING STIMULATION IN UNINTENDED AREAS. REPROGRAMMING WAS UNSUCCESSFUL. AN IMPEDANCE CHECK REVEALED NO ANOMALIES. X-RAYS REVEALED LEAD MIGRATION. THE PATIENT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202306 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3136785 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention | SCS IPG, MODEL: 3788| IMPLANT: |