FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 3182170
·
Received June 14, 2013
Report
- Report Number
- 1627487-2013-01697
- Event Type
- Injury
- Date Received
- June 14, 2013
- Date of Event
- April 17, 2013
- Report Date
- May 23, 2013
- Manufacturer
- ST. JUDE MEDICAL -NEUROMODULATION
- Product Code
- GZB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFO 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: 1627487-2013-01698. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE STIMULATION AND IS RECEIVING UNINTENDED RIB STIMULATION. MULTIPLE REPROGRAMMING ATTEMPTS HAVE BEEN UNABLE TO RESOLVE THE ISSUE. THE PATIENT WAS REFERRED TO A NEUROSURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270759 | OCTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL -NEUROMODULATION | 3186 | 3915838 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other | SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: |