FDA Adverse Event
Injury
Summary report: N
OCTRODE LEAD KIT, 60CM LENGTH
MDR report key: 8765990
·
Received July 7, 2019
Report
- Report Number
- 3006705815-2019-02540
- Event Type
- Injury
- Date Received
- July 7, 2019
- Date of Event
- April 14, 2017
- Report Date
- July 16, 2019
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
- Product Code
- LGW
- UDI-DI
- 05415067017246
- PMA / PMN Number
- P010032
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EXPLANT, CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES WERE INADVERTENTLY ENTERED INCORRECTLY IN INITIAL REPORT.
Additional Manufacturer Narrative · 1
THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
Description of Event or Problem · 1
DEVICE 1 OF 2. REFERENCE MFR. REPORT#: 3006705815-2019-02679.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE THERAPY. AS A RESULT, THE PATIENT'S SCS SYSTEM WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559729 | OCTRODE LEAD KIT, 60CM LENGTH | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) | 3186 | A000028311 | 05415067017246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |