FDA Adverse Event
Injury
Summary report: N
OCTRODE LEAD KIT, 60CM LENGTH
MDR report key: 9301534
·
Received November 8, 2019
Report
- Report Number
- 1627487-2019-12584
- Event Type
- Injury
- Date Received
- November 8, 2019
- Date of Event
- October 21, 2019
- Report Date
- November 11, 2019
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED WHEN THE EVALUATION IS COMPLETED.
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE, AND THE ROOT CAUSE OF THE REPORTED INCIDENT IS UNKNOWN AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS
Description of Event or Problem · 1
RELATED MFR REPORT: 1627487-2019-012585. IT WAS REPORTED THE PATIENT'S SCS LEADS MIGRATED. SURGICAL INTERVENTION WAS TAKEN TO REVISE AND MOVE THE LEADS DOWN. EFFECTIVE STIMULATION THERAPY WAS SUCCESSFULLY RESTORED POSTOPERATIVE.
Description of Event or Problem · 1
RELATED MFR REPORT: 1627487-2019-012585.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1091496 | OCTRODE LEAD KIT, 60CM LENGTH | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 173008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |