OCTRODE LEAD KIT, 60CM LENGTH
Report
- Report Number
- 3006705815-2022-17986
- Event Type
- Injury
- Date Received
- November 10, 2022
- Date of Event
- October 17, 2022
- Report Date
- February 8, 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
- KY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DATE OF EVENT ESTIMATED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.
BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-17987. IT WAS REPORTED THE PATIENT LEADS HAD MIGRATED AND WAS EXPERIENCING INEFFECTIVE STIMULATION. SURGICAL INTERVENTION MAY TAKE PLACE AT A FUTURE DATE TO ADDRESS THE ISSUE.
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT SURGICAL INTERVENTION TOOK PLACE WHERE THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. COVERAGE WAS RESTORED AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1515984 | OCTRODE LEAD KIT, 60CM LENGTH | PERCUTANEOUS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) | 3186 | A000124719 | 05415067017246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other | SCS ANCHORS (X2)| SCS IPG (X1) |