BEUDAMED
    FDA Adverse Event Death Summary report: N

    KAPPA 900 SR

    MDR report key: 1921225 · Received December 13, 2010

    Report

    Report Number
    6000094-2010-02164
    Event Type
    Death
    Date Received
    December 13, 2010
    Date of Event
    May 31, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS FULLY FUNCTIONAL WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. THE DEVICE DID NOT MEET ITS 99.9% OF ITS EXPECTED LONGEVITY. BOTH LOADED AND UNLOADED PACING CURRENT DRAIN LEVELS WERE NORMAL FOR THIS DEVICE AT RECEIVED AND BOL (BEGINNING OF LIFE) VOLTAGES. THERE IS NO EVIDENCE TO INDICATE A PROBLEM WITH THE BATTERY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011 WHERE AN ATTORNEY ALLEGES THAT APPROXIMATELY THREE YEARS POST DEVICE IMPLANT, THE PATIENT BEGAN TO EXPERIENCE INCREASING PROBLEMS TO HEALTH INCLUDING SHORTNESS OF BREATH, SWELLING OF THE LEGS AND FEET AND RETENTION OF FLUID IN THE LUNGS. FURTHER ALLEGES THE PATIENT WAS ADVISED THE PACEMAKER WAS MALFUNCTIONING. THE PATIENT'S DEVICE WAS REPLACED HOWEVER; THE PATIENT'S CONDITION DETERIORATED AND THE PATIENT PASSED AWAY EIGHT MONTHS POST DEVICE REPLACEMENT. ADDITIONALLY, ALLEGES THAT THE PATIENT SUSTAINED INJURIES INCLUDING BUT NOT LIMITED TO REPEAT SURGERY, DAMAGE TO THE HEART AND TO THE HEART'S SURROUNDING STRUCTURES. THE PATIENT REQUIRED FURTHER MEDICAL AND HOSPITAL TREATMENT IN CONDITION WITH THE "FAULTY" PACEMAKER. ALL RELEVANT SECTIONS HAVE BEEN UPDATED ACCORDINGLY. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS FULLY FUNCTIONAL WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. THE DEVICE DID NOT MEET ITS 99.9% OF ITS EXPECTED LONGEVITY. BOTH LOADED AND UNLOADED PACING CURRENT DRAIN LEVELS WERE NORMAL FOR THIS DEVICE AT RECEIVED AND BOL (BEGINNING OF LIFE) VOLTAGES. THERE IS NO EVIDENCE TO INDICATE A PROBLEM WITH THE BATTERY.

    Description of Event or Problem · 1

    A FAMILY MEMBER OF THE PATIENT REPORTED THE DEVICE BATTERY FAILED. THE FAMILY MEMBER REPORTS THE PATIENT, WHO HAD BEEN PREVIOUSLY ACTIVE, HAD EXPERIENCED DETERIORATING HEALTH. THE PATIENT STARTED TO TIRE EASILY, HAD SHORTNESS OF BREATH, AND LEGS SWELLED WITH FLUID. DURING A DEVICE CHECK, THE PATIENT REPORTEDLY LEARNED THE "BATTERY WAS DEFECTIVE AS OF (B)(6) 2010" AND REQUIRED URGENT REPLACEMENT. PRIOR TO THIS, THE FAMILY HAD BEEN ADVISED THAT THE DEVICE BATTERY WOULD LAST SEVEN YEARS AT ITS CURRENT USAGE. THE FAMILY MEMBER FURTHER REPORTS THAT "CLEARLY THE BATTERY WAS FAULTY" AND THE PATIENT NO LONGER WILL ENJOY THE SAME QUALITY OF LIFE AS EXPERIENCED EARLIER. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE INDICATED THAT DURING A ROUTINE DEVICE CHECK AT THE CLINIC, IT WAS NOTED THAT ELECTIVE REPLACEMENT INDICATOR HAD OCCURRED IN (B)(6) 2010, AND THE DEVICE WAS PACING AT VVI 65 BPM. THE DEVICE WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 900 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. KSR903 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD