FDA Adverse Event
Injury
Summary report: N
OCTRODE LEAD KIT, 60CM LENGTH
MDR report key: 17242072
·
Received June 30, 2023
Report
- Report Number
- 3006705815-2023-04103
- Event Type
- Injury
- Date Received
- June 30, 2023
- Date of Event
- June 15, 2023
- Report Date
- September 15, 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
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
Additional Manufacturer Narrative · 0
DATE OF THE EVENT IS ESTIMATED. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7133036.
Description of Event or Problem · 0
THE INVESTIGATION DID NOT DETERMINE WHICH LEAD HAD HIGH IMPEDANCES.
Description of Event or Problem · 0
IT WAS REPORTED THE PATIENT HAS INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. AS SUCH, SURGICAL INTERVENTION MAY OCCUR TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23571 | OCTRODE LEAD KIT, 60CM LENGTH | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) | 3186 | A000084934 | 05415067017246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other | SCS ANCHOR (2)| SCS IPG| SCS LEAD |