FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 4180040
·
Received October 15, 2014
Report
- Report Number
- 1627487-2014-01651
- Event Type
- Injury
- Date Received
- October 15, 2014
- Date of Event
- September 22, 2014
- Report Date
- September 22, 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 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
THE PATIENT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT IS WITHOUT EFFECTIVE THERAPY. REPORTEDLY, X-RAYS REVEALED THE LEADS HAVE MIGRATED. SURGICAL INTERVENTION MAY BE UNDERTAKEN AS THE NEXT COURSE OF ACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653686 | OCTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3189 | 4122325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other | SCS IPG: MODEL 3789| IMPLANT DATE: |