OCTRODE LEAD KIT, 60CM LENGTH
Report
- Report Number
- 1627487-2022-06461
- Event Type
- Injury
- Date Received
- November 26, 2022
- Report Date
- January 17, 2023
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- LGW
- UDI-DI
- 05414734406130
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3186, UDI: (B)(4), SERIAL:(B)(4), BATCH:4946260. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE DEVICE INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.
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: 1627487-2022-06451. IT WAS REPORTED THAT THE PATIENT LOST THERAPY DUE TO IPG BEING INOPERABLE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED WITH A NEW IPG TO ADDRESS THE ISSUE. ADDITIONALLY, ONE OF THE PATIENT'S LEADS WAS ALSO EXPLANTED AND REPLACED WITH A NEW LEAD FOR AN UNKNOWN REASON. REPORTEDLY, THERAPY WAS CONFIRMED POST OP. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THAT DURING THE IPG REPLACEMENT IT WAS DISCOVERED THAT ONE OF THE LEADS HAD MIGRATED. HENCE, THE LEAD WAS REPLACED TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2536202 | OCTRODE LEAD KIT, 60CM LENGTH | PERCUTANEOUS LEAD | LGW | ABBOTT MEDICAL | 3186 | 4887174 | 05414734406130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other | SCS ANCHOR (X2)| SCS LEAD |