FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 4112988
·
Received September 17, 2014
Report
- Report Number
- 1627487-2014-20223
- Event Type
- Injury
- Date Received
- September 17, 2014
- Date of Event
- August 26, 2014
- Report Date
- August 26, 2014
- 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
- 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
DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2014-20224. IT WAS REPORTED THE PT EXPERIENCED UNINTENDED ABDOMINAL STIMULATION. AS A RESULT, SURGICAL INTERVENTION WAS TAKEN TO REPOSITION THE LEADS WHICH RESOLVED THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 574220 | OCTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3858973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other | SCS IPG: MODEL 3788| IMPLANT DATE: |