FDA Adverse Event
Injury
Summary report: N
OCTRODE LEAD KIT, 60CM LENGTH
MDR report key: 4893536
·
Received July 6, 2015
Report
- Report Number
- 1627487-2015-12345
- Event Type
- Injury
- Date Received
- July 6, 2015
- Date of Event
- June 10, 2015
- Report Date
- July 14, 2015
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PRODUCTS: MODEL 3416, SCS RECEIVER, IMPLANT DATE: UNKNOWN. 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.
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 2 OF 2. REFERENCE MFR REPORT 1627487-2015-12344.
Description of Event or Problem · 1
DEVICE 2 OF 2. REFERENCE MFR REPORT 1627487-2015-12344.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 435207 | OCTRODE LEAD KIT, 60CM LENGTH | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | A1078008004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |