FDA Adverse Event
Injury
Summary report: N
QUATTRODE LEAD WIDE SPACED, 60 CM
MDR report key: 6192778
·
Received December 21, 2016
Report
- Report Number
- 1627487-2016-06476
- Event Type
- Injury
- Date Received
- December 21, 2016
- Report Date
- November 28, 2016
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZF
- PMA / PMN Number
- K072462
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 4 OF 4. REFERENCE MFR REPORTS 1627487-2016-06473, 1627487-2016-06474, 1627487-2016-06475. IT WAS REPORTED THE PATIENT'S OCCIPITAL (OFF LABEL USE) SYSTEM WAS EXPLANTED DUE TO INEFFECTIVE STIMULATION. THE PATIENT ALSO REQUIRED A CONTRAINDICATED PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 843639 | QUATTRODE LEAD WIDE SPACED, 60 CM | SCS LEAD | GZF | ST. JUDE MEDICAL - NEUROMODULATION | 3166 | 5380949 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | MODEL 3341, SCS EXTENSION| MODEL 3789, SCS IPG |