RX PACING LEAD

Additional Manufacturer Narrative

DURING OUR FINAL INVESTIGATION, IT WAS DISCOVERED THE INITIAL MDR 1035166-2018-00057 REPORT HAD FAILED SUBMISSION. BASED UPON OUR FINDINGS, WE HAVE RESUBMITTED THIS INITIAL MDR REPORT. THE LEAD IN QUESTION WAS CAPPED, NOT EXPLANTED. CONCOMITANT MEDICAL PRODUCT: K173 SERIAL (B)(4) - EXPLANTED DUE TO OTHER/NON-PRODUCT EXPERIENCE- UNKNOWN DATE. THE DEVICE HISTORY RECORDS FOR THIS LEAD MODEL GOES BEYOND OSCOR'S RECORD RETENTION PERIOD, HOWEVER, INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. A REVIEW OF THE QA PERMANENT PACING LEAD FINAL INSPECTION PROCEDURE INDICATES THAT THE LEAD IS CHECKED 100 PERCENT FOR ELECTRICAL FUNCTION. THE PROCEDURE INCLUDES "ACCEPTANCE CRITERIA ALL PRODUCTS MUST MEET PRE-DETERMINED SPECIFICATIONS IN EACH STEP OF THIS PROCEDURE. IF PRODUCT DOES NOT COMPLY WITH SPECIFICATIONS, IT MUST BE REJECTED. AN UNUSUAL OR QUESTIONABLE OR OFTEN REPEATING DEFECT MUST BE REPORTED TO QA MANAGEMENT IMMEDIATELY." ELECTRICAL FUNCTION: ELECTRICAL RESISTANCE HAS TO BE CHECKED WITH A MULTIMETER. RECORD OHMS READINGS ON WORK ORDER. ALL TUBING WILL BE INSPECTED ACCORDING TO THE CRITERIA/INSPECTION OF POLYURETHANE AND SILICONE TUBING PROCEDURE. THE ELECTRODES SHOULD BE CLEAN AND HAVE NO ADHESIVE OR OTHER RESIDUE. ELECTRODES SHOULD BE SMOOTH AND FREE OF SCRATCHES. THE PERMANENT IMPLANTABLE PACING LEADS INSTRUCTIONS FOR USE (IFU), PROVIDES INFORMATION ON THE FOLLOWING 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 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. THE LEAD WAS IN USE FOR TREATMENT FOR OVER 21 YEARS PRIOR TO BEING CAPPED AND ABANDONED. AS THE LEAD WAS CAPPED, IT WAS NOT RETURNED FOR ANALYSIS. AS A RESULT, THE ALLEGATIONS AGAINST THIS LEAD CANNOT BE CONFIRMED AND A ROOT CAUSE OF THE HIGH THRESHOLD COULD NOT BE DETERMINED. NO SUBSEQUENT DEVICE OR CLINICAL ADVERSE EVENTS HAVE BEEN REPORTED. THRESHOLD ELEVATION IS A RECOGNIZED CLINICAL EVENT REFERENCED IN THE DEVICE'S LABELING. THIS LEAD IS NO LONGER MANUFACTURED BY OSCOR. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE AND RISK.

Description of Event or Problem

ON (B)(6) 2018 THE ORIGINAL RV LEAD (RX58TBV /SERIAL NUMBER (B)(4)) WAS CAPPED DUE TO HIGH THRESHOLDS AND 7741 882197 WAS PLACED. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT A FEW DAYS AFTER THE (B)(6) 2018 IMPLANT WITH CHEST PAIN AROUND THE CAN. THE HOSPITAL TOOK AN X-RAY AND SAW A PERFORATION. THE PATIENT WAS NOT HARMED, HE WENT HOME FROM THE EMERGENCY DEPARTMENT THAT DAY AND RETURNED AS AN OUTPATIENT FOR REVISION. ON (B)(6) 2018 THE 7741 SERIAL NUMBER (B)(4) LEAD WAS EXPLANTED DUE TO PERFORATION AND LEAD 7741 SERIAL NUMBER (B)(4) WAS PLACED. NO PERFORATION WAS PRESENT OR IMPLICATED WITH THE ORIGINAL LEAD RX58TBV-SERIAL NUMBER (B)(4). THIS REPORT IS FOR THE REPORTED HIGH THRESHOLDS INVOLVING MODEL RX 58 TBV SERIAL NUMBER (B)(4) ONLY.