OCTRODE LEAD KIT, 60CM LENGTH
Report
- Report Number
- 1627487-2023-06051
- Event Type
- Injury
- Date Received
- December 22, 2023
- Date of Event
- November 16, 2023
- Report Date
- February 7, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Report Source
- Manufacturer report
- Reporter Location
- NE, 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.
DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT AND PATIENT INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 5030692.
ADDITIONAL INFORMATION REVEALED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE LEADS WERE EXPLANTED AND REPLACED. POSTOPERATIVELY, THE PATIENT HAS EFFECTIVE THERAPY.
IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING INEFFECTIVE THERAPY AS A RESULT OF AN IMPEDANCE ISSUE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1298954 | OCTRODE LEAD KIT, 60CM LENGTH | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | ABBOTT MEDICAL | 3186 | 4365527 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | SCS IPG (X1)| SCS LEAD (X1) |