PY PERMANENT PACING LEAD
Report
- Report Number
- 1035166-2022-00083
- Event Type
- Malfunction
- Date Received
- July 13, 2022
- Date of Event
- June 14, 2022
- Report Date
- November 23, 2022
- Manufacturer
- OSCOR INC.
- Product Code
- DTB
- PMA / PMN Number
- K862330
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE. 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.
H11: CORRECTION : THE LEAD REMAINS IN SERVICE FOR APPROXIMATELY 22 YEARS, 10 MONTHS SINCE THE EVENT DATE 06/14/2022. 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 USED IN TREATMENT. THE LEAD IMPLANT DATE IS (B)(6) 2000. THE LEAD WAS ABANDONED/CAPPED ON (B)(6) 2021; THEREFORE, THE LEAD WAS NOT RETURNED. BASED UPON THE IMPLANT DATE OF THIS LEAD ((B)(6) 2000). QA IS UNABLE TO REVIEW THE DEVICE HISTORY RECORD FOR THIS LEAD MODEL AS IT IS BEYOND OSCOR'S RECORD RETENTION PERIOD. INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT TO PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. HOWEVER, THE FOLLOWING CONTROLS ARE IN PLACE TO MITIGATE THE REPORTED PRODUCT ISSUE. PER QA PROCEDURE #PERMANENT PACING LEAD FINAL INSPECTION, THE DEVICE IS VERIFIED 100 PERCENT FOR ELECTRICAL AND VISUAL FUNCTION. AS STATED IN THE PROCEDURE. "ELECTRICAL FUNCTION: ELECTRICAL RESISTANCE HAS TO BE CHECKED WITH A MULTIMETER. RECORD OHMS READINGS ON WORK ORDER. NOTE: ON PY LEADS, USE HELIX TO CONNECTOR PIN AS CONTACT. "D" DIMENSIONS (IS-1 CONNECTORS): MEASURE D DIMENSION USING OPTICAL COMPARATOR. TUBING INSPECTION AND CRITERIA: ALL TUBING WILL BE INSPECTED ACCORDING TO PROCEDURE, "CRITERIA/INSPECTION OF POLYURETHANE AND SILICONE TUBING". THE ELECTRODES SHOULD BE CLEAN AND HAVE NO ADHESIVE OR OTHER RESIDUE. ELECTRODES SHOULD BE SMOOTH AND FREE OF SCRATCHES. (CHECK WITH Z FOAM DAMPENED WITH ALCOHOL.)" THE PY SERIES INSTRUCTIONS FOR USE (IFU) INFORMS THE USER OF LONG TERM CLINICAL EXPERIENCE FOR ACUTE AND CHRONIC DATA MEASUREMENTS FOR SENSING THRESHOLD AND IMPEDANCE. THE INSTRUCTIONS FOR USE (IFU) INFORMS THE USER OF THESE POSSIBLE COMPLICATIONS: WITH THE USE OF ENDOCARDIAL LEADS, COMPLICATIONS MIGHT OCCUR DURING IMPLANTATION, EXPLANTATION, OR AT ANY TIME POSTOPERATIVELY AND MAY REQUIRE NON-INVASIVE OR INVASIVE TECHNIQUES FOR MANAGEMENT, AS DETERMINED BY THE CLINICAL JUDGMENT OF THE PHYSICIAN. INTERMITTENT OR CONTINUOUS LOSS OF PACING OR SENSING CAN BE CAUSED BY A DISPLACEMENT OF THE ELECTRODE, UNSATISFACTORY ELECTRODE POSITION, BREAKAGE OF THE CONDUCTOR OR ITS INSULATION, AN INCREASE IN THRESHOLDS, OR POOR ELECTRICAL CONNECTION TO THE PULSE GENERATOR. IN ADDITION, THE IFU PROVIDES THE USER PRODUCT AWARENESS: THE PACING LEADS ARE IMPLANTED IN THE EXTREMELY HOSTILE ENVIRONMENT OF THE HUMAN BODY. BECAUSE THE LEADS ARE VERY SMALL IN DIAMETER AND MUST BE VERY FLEXIBLE, IT INEVITABLY REDUCES THEIR POTENTIAL PERFORMANCE AND LONGEVITY. LEADS MAY FAIL TO FUNCTION FOR A VARIETY OF CAUSES, INCLUDING MEDICAL COMPLICATIONS, BODY REJECTION PHENOMENON, FIBROTIC TISSUE PROBLEM, OR A FAILURE OF LEAD BY DAMAGE, FRACTURE, OR BY BREACH OF THEIR INSULATION. DESPITE OF ALL CARE IN DESIGN, COMPONENT QUALITY, MANUFACTURE AND TESTING PRIOR TO SALE, LEADS MAY BE DAMAGED BY IMPROPER HANDLING, USE, PLACEMENT OR OTHER INTERVENING FACTS. THE IFU PRECAUTIONS THE USER: PERFORM PROCEDURE UNDER FLUOROSCOPIC GUIDANCE. THIS LEAD IS NO LONGER MANUFACTURED BY OSCOR. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS DEVICE FOR COMPLAINT TRENDS. 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.
IT WAS REPORTED THAT THIS RIGHT ATRIAL LEAD EXHIBITED LOW WITHIN RANGE IMPEDANCE MEASUREMENTS. FURTHER EVALUATION OF THE DEVICE WAS SUGGESTED. THIS LEAD REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470064 | PY PERMANENT PACING LEAD | PERMANENT PACEMAKER ELECTRODE, PRODUCT CODE: DTB | DTB | OSCOR INC. | PY 52 PSBV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female |