FDA Adverse Event
Injury
Summary report: N
OCTRODE LEAD KIT, 60CM LENGTH
MDR report key: 15739930
·
Received November 4, 2022
Report
- Report Number
- 3006705815-2022-17651
- Event Type
- Injury
- Date Received
- November 4, 2022
- Date of Event
- October 20, 2022
- Report Date
- January 9, 2023
- 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
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF THE EVENT IS ESTIMATED.
Additional Manufacturer Narrative · 0
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem · 0
RELATED MANUFACTURER REFERENCE NUMBER:3006705815-2022-17654. IT WAS REPORTED THE PATIENT'S LEADS HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE EXISTING LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2212280 | OCTRODE LEAD KIT, 60CM LENGTH | PERCUTANEOUS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) | 3186 | A000096789 | 05415067017246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other | SCS ANCHOR (2)| SCS IPG |