RX PERMANENT PACING LEAD
Report
- Report Number
- 1035166-2021-00140
- Event Type
- Injury
- Date Received
- November 19, 2021
- Date of Event
- October 4, 2021
- Report Date
- April 22, 2021
- Manufacturer
- OSCOR INC.
- Product Code
- DTB
- PMA / PMN Number
- K862966
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
H2 CORRECTION: MADE CORRECTION TO SECTION G4, SHOULD BE K862966. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
THE LEAD WAS IN SERVICE FOR APPROXIMATELY 26 YEARS BEFORE BEING EXPLANTED ON (B)(6) 2021. ONE RX 52 TJBV IMPLANTABLE LEAD WAS RETURNED FROM THE CUSTOMER. THERE WERE NO OTHER ACCESSORIES. THE IMPLANTABLE LEAD WAS RETURNED INCOMPLETELY, LACKING PARTS, COMPONENTS OR ACCESSORIES THAT WOULD BE REQUIRED FOR APPROPRIATE TESTING AND ANALYSIS OF ROOT CAUSE. THE LEAD'S OUTER INSULATION IS IN VERY POOR CONDITION WITH NUMEROUS AREAS OF DAMAGE (INSULATION MELTED, CUT, ABRADED) RUNNING IRREGULARLY ALONG THE ENTIRE LENGTH OF THE LEAD. THE FILARS INSIDE THE LEAD ARE BROKEN, TWISTED AND STRETCHED AND THE LEAD HAS AN EXTRACTION DEVICE ATTACHED TO IT. THE EXACT CAUSE OF THE LEAD ISSUE CANNOT BE DETERMINED AND THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. QA IS UNABLE TO REVIEW THE DEVICE HISTORY RECORDS FOR THIS LEAD MODEL AS IT IS BEYOND OSCOR'S RECORD RETENTION PERIOD, HOWEVER, INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT TO PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED. THIS LEAD IS NO LONGER MANUFACTURED BY OSCOR. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE.
IT WAS REPORTED THE PATIENT WAS PRESENTED TO THE HOSPITAL FOR AN EXPLANT PROCEDURE DUE TO PATIENT HAVING CORYNIE BACTERIUM INFECTION, NOT RELATED TO THE ATRIAL LEAD. DURING THE PROCEDURE, WHILE ATTEMPTING TO EXPLANT THE ATRIAL LEAD, IT WAS NOTED TO BE FRACTURED. THE LEAD WAS EXPLANTED AND THE PATIENT IS IN STABLE CONDITION. NO ADDITIONAL INFORMATION AVAILABLE. REFERENCE REPORT 1035166-2021-00142 ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1742204 | RX PERMANENT PACING LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | OSCOR INC. | RX 52 TJBV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Hospitalization| R |