OCTRODE LEAD KIT, 60CM LENGTH
Report
- Report Number
- 1627487-2023-02509
- Event Type
- Injury
- Date Received
- May 24, 2023
- Date of Event
- February 7, 2023
- Report Date
- February 9, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- LGW
- UDI-DI
- 05415067017246
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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 (B)(6); 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.
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.
RELATED MANUFACTURER REPORT NUMBER: 3006705815-2023-01169. IT WAS REPORTED THAT THE PATIENT'S LEAD WAS EXPLANTED AND REPLACED DUE TO LEAD FRACTURE.
ADDITIONAL INFORMATION RECEIVED INDICATES THAT HIGH IMPEDANCES WERE ALSO OBSERVED WITH THIS LEAD PRIOR TO REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 760977 | OCTRODE LEAD KIT, 60CM LENGTH | PERCUTANEOUS LEAD | LGW | ABBOTT MEDICAL | 3186 | 7110413 | 05415067017246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |