OCTRODE LEAD KIT, 60CM LENGTH
Report
- Report Number
- 3006705815-2024-02507
- Event Type
- Injury
- Date Received
- April 4, 2024
- Date of Event
- March 22, 2024
- Report Date
- July 1, 2024
- 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
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
DATE OF EVENT IS ESTIMATED. 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. THE ALLEGATION IS AGAINST 1 OF 2 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: OCTRODE LEAD, MODEL: 3186ANS, SERIAL: (B)(6), UDI: (B)(4), BATCH: 7110413.
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT WAS ALSO UNABLE TO SET THEIR IPG TO MRI MODE DUE TO HIGH IMPEDANCES.
IT WAS REPORTED THAT THE PATIENT MAY EXPLANT THEIR SYSTEM DUE TO INEFFECTIVE THERAPY. NO FURTHER INFORMATION WILL BE PROVIDED. IT IS UNKNOWN WHICH LEAD HAD CAUSED THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2018566 | OCTRODE LEAD KIT, 60CM LENGTH | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) | 3186 | A000082967 | 05415067017246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other | SCS IPG.| SCS LEAD ANCHOR (X2).| SCS LEAD. |