FDA Adverse Event
Injury
Summary report: N
OCTRODE LEAD KIT, 60CM LENGTH
MDR report key: 6167617
·
Received December 12, 2016
Report
- Report Number
- 1627487-2016-06363
- Event Type
- Injury
- Date Received
- December 12, 2016
- Report Date
- January 19, 2017
- 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
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
(B)(4).
Description of Event or Problem · 1
DEVICE 2 OF 2. REFERENCE MFR REPORT# 1627487-2016-06362.
Description of Event or Problem · 1
DEVICE 2 OF 2. REFERENCE MFR REPORT#1627487-2016-06362. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH TIME THE LEADS WERE EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 816450 | OCTRODE LEAD KIT, 60CM LENGTH | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 4844687 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | MODEL 1192, SCS ANCHOR| MODEL 1192, SCS ANCHOR| MODEL 3789, SCS IPG |