FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 3231474
·
Received July 12, 2013
Report
- Report Number
- 1627487-2013-15974
- Event Type
- Injury
- Date Received
- July 12, 2013
- Date of Event
- December 28, 2012
- Report Date
- December 28, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- 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 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: 1627487-2013-15975. THE PT HAD 3 LEADS (2 FROM ONE LOT AND 1 FROM A DIFFERENT LOT) IMPLANTED AS PART OF HIS SCS SYSTEM. IT WAS REPORTED THE PT THE PT EXPERIENCED INEFFECTIVE COVERAGE OF HIS BACK. SURGICAL INTERVENTION WAS UNDERTAKEN AND A SURGICAL LEAD WAS IMPLANTED. THE PT HAS BEEN REPROGRAMMED MULTIPLE TIMES SINCE UNDERGOING SURGICAL INTERVENTION ALL TO NO AVAIL. REFERENCE MFR REPORTS: 1627487-2013-13522 AND MFR REPORT: 1627487-2013-15954.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324722 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3209017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other | SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| SCS EXTENSION: MODEL 3341| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE: |