FDA Adverse Event
Injury
Summary report: N
OCTRODE LEAD KIT, 60CM LENGTH
MDR report key: 8678883
·
Received June 7, 2019
Report
- Report Number
- 3006705815-2019-02139
- Event Type
- Injury
- Date Received
- June 7, 2019
- Date of Event
- May 22, 2019
- Report Date
- June 16, 2019
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
- Product Code
- LGW
- UDI-DI
- 05415067017246
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
Description of Event or Problem · 1
REFERENCE MFR. REPORT NUMBER: 3006705815-2019-021398.
Description of Event or Problem · 1
REFERENCE MFR. REPORT NUMBER: 3006705815-2019-02138. IT WAS REPORTED THAT ONE OF PATIENT LEADS ERODED THROUGH THE SKIN. ADDITIONAL INFORMATION RECEIVED, THAT PATIENT WENT TO URGENT CARE AND THE WOUND SCABBED OVER THE LEAD AND EVERYTHING IS WORKING FINE. PATIENT REPORTS NO FEVER OR INFECTION. IT IS UNKNOWN WHICH LEAD IS LIABLE SO BOTH LEADS ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 473489 | OCTRODE LEAD KIT, 60CM LENGTH | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) | 3186 | A000034220 | 05415067017246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | MODEL 3186, SCS LEAD |