BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXION PERMANENT PACING LEAD

    MDR report key: 11274284 · Received February 3, 2021

    Report

    Report Number
    1035166-2021-00004
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    December 6, 2019
    Report Date
    April 6, 2021
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K964107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL EVENT INFORMATION PROVIDED FOR PATIENT'S MEDICAL CONDITION AND TREATMENTS. ADDING DATE OF MANUFACTURING. 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. 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.

    Description of Event or Problem · 0

    CUSTOMER CALLED TO GET A NEW MEDICAL ID CARD PER PATIENT, RT. MUPLTIPLE DEVICE IMPLANTS SINCE 2002. FIRST AND SECOND ONES WAS RECALLED, AND SOMETHING ELSE WITH THE THIRD ONE. CURRENT ONE IS MIGRATING AND MIGHT HAVE STAPH INFECTION. SWOLLEN AREA AROUND DEVICE. PATIENT WAS IN THE HOSPITAL FOR ABOUT A YEAR IN 2019 FIGHTING CANCER. HAD SWELLING AROUND THE INCISION. DEVICE IS MIGRATING AROUND BECAUSE THE DOCTOR DIDN'T SECURE DEVICE IN THE POCKET.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS IMPLANTED FOR TREATMENT. THE LEAD REMAINS IN SERVICE FOR APPROXIMATELY 17 YEARS, 6 MONTHS, SINCE THE EVENT DATE (B)(6) 2019. THE LEAD IS STILL IMPLANTED AND IN USE FOR TREATMENT, THEREFORE, THE EXACT CAUSE OF THE LEAD ISSUE CANNOT BE DETERMINED AND THE REPORTED CLINICAL OBSERVATION CANNOT BE CONFIRMED. BASED UPON THE IMPLANT DATE OF THIS LEAD (2002), THE DEVICE HISTORY RECORD FOR THIS LEAD MODEL 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. PERMANENT PACING LEAD FINAL INSPECTION PROCEDURE FOR THIS DEVICE INDICATES THAT THE LEAD IS CHECKED 100% FOR ELECTRICAL FUNCTION. FINAL QA INSPECTION OF PERMANENT PACING LEADS INCLUDES AN INSERTION/WITHDRAWAL FORCE TEST ON IS-1 CONNECTOR ON THE FIRST AND LAST SERIAL NUMBER OF THE WORK ORDER AND 100% INSPECTION REGARDING: LENGTH MEASUREMENT OF THE LEAD, DISTAL SPACING MEASUREMENT, PULL TEST ON THE CONNECTOR, ELECTRICAL DC RESISTANCE IS CHECKED RING TO RING, PIN TO TIP AND PIN TO RING (ON PR LEADS, USE HELIX TO CONNECTOR PIN AS CONTACT), MEASUREMENT OF "D" DIMENSION ON IS-1 CONNECTOR AND TUBING INSPECTION IS DONE. FOLLOWING A GENERAL INSPECTION IS DONE OF THE FOLLOWING: VERIFY PROPER APPLICATION OF ADHESIVE, CHECK OUTER HULL TO INNER HULL LASER WELD FOR PROPER PLACEMENT, COIL IS CHECKED FOR KINKS, THE CONNECTOR SLEEVE AND ORINGS ARE EXAMINED FOR NICKS, CUTS, EXCESSIVE FLASH OR EXCESSIVE ADHESIVE RESIDUES ON ITS SURFACE, ELECTRODES ARE EXAMINED FOR RESIDUE AND SCRATCHES, ROTATIONAL PIN TO PIN HULL LASER WELD IS CHECKED FOR PROPER WELD, AND HELIX IS CHECKED BY EXTENSION AND RETRACTION. PRIOR TO PACKAGING THE HELIX IS COMPLETELY RETRACTED AND PROTECTOR TUBING IS ATTACHED. PER INSTRUCTIONS FOR USE (IFU) PR FLEXION INFORMS THE USER OF THESE POSSIBLE COMPLICATIONS: WITH THE USE OF ENDOCARDIAL LEADS, COMPLICATIONS CAN 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, ALLERGIC REACTION, FIBROTIC TISSUE, OR A FAILURE OF LEAD BY BREAKAGE, FRACTURE, OR BY BREACH OF THEIR INSULATION COVERING. THE IFU PRECAUTIONS THE USER: PERFORM PROCEDURE UNDER FLUOROSCOPIC GUIDANCE. NO FURTHER FOLLOW-UP IS REQUIRED. THE DEVICE WAS NOT RETURNED AND THERE WAS NO SPECIFIC PERFORMANCE RELATED FAILURE REPORTED BY THE USER. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT IS A (B)(6) YEAR OLD MALE WHO HAS CONCERNS THAT HIS DEVICE WAS NOT WORKING PROBABLY. THE PATIENT STATED HE RECEIVED THE D143 / 201392 DEVICE FROM A DIFFERENT DOCTOR. THE PATIENT STATED HE CANNOT LIFT HIS ARM VERY HIGH AND HAS HAD 9 INFECTIONS, HAD DEVICES PUSH THRU THE SKIN AND SWELLING AND PAIN AROUND THE SITE. PATIENT SPENT OVER A YEAR IN THE HOSPITAL. PATIENT STATED THE DEVICE IS MIGRATING AND MIGHT HAVE STAPHYLOCOCCUS AUREUS INFECTION. PATIENT SAW A DR. AT (B)(6) HOSPITAL PRESCRIBED NUMBING CREAM. ACCORDING TO THE PATIENT, THERE WAS A SWOLLEN AREA AROUND THE DEVICE SYSTEM. PATIENT STATES HE CANNOT HAVE ANYTHING DONE WITH THE DEVICE BECAUSE IF HE IS CUT HE HAS A 75% CHANCE OF GETTING A STAPH INFECTION. ON 01/20/2021 CUSTOMER REPORTED PATIENT DID NOT RECEIVE INTERVENTION. CUSTOMER STATED THE EVENT IS SPECIALLY RELATED TO THE PACEMAKER/DEFIBRILLATOR (D143/201392); HOWEVER THE LEAD ((B)(4)) IS PART OF THE DEVICE SYSTEM, THEREFORE IS PART OF THE EVENT DUE TO THE REPORTED INFECTIONS. THE LEAD IS POSITIONED IN THE RIGHT VENTRICLE. THERE WAS NO REPORTED INTERVENTION OR OUTCOME REPORTED. THE DEVICE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171913 FLEXION PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE, PRODUCT CODE: DTB DTB OSCOR INC. 4017

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L