LEAD MODEL 302
Report
- Report Number
- 1644487-2021-00492
- Event Type
- Malfunction
- Date Received
- April 9, 2021
- Date of Event
- March 17, 2021
- Report Date
- November 23, 2021
- Manufacturer
- LIVANOVA USA, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5 DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: SUPPLEMENTAL #01 REPORT INADVERTENTLY LEFT OUT RELEVANT INFORMATION F10 ADVERSE EVENT PROBLEM, CORRECTED DATA: SUPPLEMENTAL #01 REPORT INADVERTENTLY LEFT OUT CODE 'A040101' H6 ADVERSE EVENT PROBLEM, CORRECTED DATA: SUPPLEMENTAL #01 REPORT INADVERTENTLY DID NOT CODE 'C070603' FOR INVESTIGATION FINDINGS AND 'D02' FOR INVESTIGATION CONCLUSIONS.
INFORMATION OBTAINED THAT THE PATIENT HAD STARTED EXPERIENCING AN INCREASE IN SEIZURES. PATIENT UNDERWENT LEAD REPLACEMENT SURGERY. THE EXPLANTED LEAD HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE.
DURING THE LEAD REVISION SURGERY BEFORE THE LEAD WAS REPLACED IT WAS NOTED THAT THE LEAD PIN WAS ADJUSTED, BUT THE LEAD IMPEDANCE WAS STILL HIGH SO THE SURGEON PROCEEDED WITH A LEAD REVISION.
PATIENT PRESENTED WITH HIGH LEAD IMPEDANCE AND CHEST X-RAYS WERE ORDERED AND THE PATIENT WAS REFERRED TO NEUROSURGERY. THE X-RAYS WERE REVIEWED BY THE SURGEON AND HE COULD NOT IDENTIFY A DEFINITE FRACTURE. THE X-RAYS HAVE NOT BEEN REVIEWED BY THE MANUFACTURER TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 540329 | LEAD MODEL 302 | LEAD | LYJ | LIVANOVA USA, INC. | 302-20 | 200241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female |