FDA Adverse Event
Injury
Summary report: N
OCTRODE LEAD KIT, 60CM LENGTH
MDR report key: 15786238
·
Received November 13, 2022
Report
- Report Number
- 3006705815-2022-18034
- Event Type
- Injury
- Date Received
- November 13, 2022
- Date of Event
- October 20, 2022
- Report Date
- January 10, 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
- IL, 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.
Description of Event or Problem · 0
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-18033. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION. X-RAYS SHOWED THAT BOTH THE PATIENTS LEADS HAD MIGRATED. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THIS ISSUE.
Description of Event or Problem · 0
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-18033. ADDITIONAL INFORMATION RECEIVED INDICATES THAT SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2022, WHERE ONE LEAD WAS EXPLANTED AND REPLACED, AND THE OTHER LEAD WAS REPOSITIONED. THERAPY RESTORED POST-OP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351128 | OCTRODE LEAD KIT, 60CM LENGTH | PERCUTANEOUS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) | 3186 | A000123464 | 05415067017246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other | SCS IPG |