BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3993077 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01086
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-1661-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED FUNCTIONAL TESTING WITH NO ANOMALIES FOUND. IT WAS NOTED THAT THERE WERE CRACKS AROUND THE HOUSING FIXING SCREW. BENCH TESTING DID NOT REVEAL ANY ANOMALIES. A LONG-TERM TEST WAS PERFORMED FOR 12 DAYS, THE LOW BATT INDICATION WAS CONFIRMED TO LAST 24 HOURS. THE CASE WAS REPLACED, CIRCUIT BOARD WAS CLEANED AND DEVICE WAS CALIBRATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR BRADYCARDIA. A TEMPORARY LEAD WAS INSERTED FROM THE FEMUR AND PATIENT WAS HOSPITALIZED. THE PATIENT HAD BEEN ALMOST FULLY DEPENDING ON AN EXTERNAL PULSE GENERATOR (EPG) FOR PACING, THE TEMPORARY LEAD WAS RE-INSERTED FROM THE JUGULAR VEIN, AS IT WAS CONSIDERED THAT THE PATIENT'S STAY WOULD BE PROLONGED OTHERWISE, ALSO THE EPG WAS CHANGED AT THIS TIME. A DAY LATER THE NURSE NOTICED AN ECG ALERT FOR CARDIAC ARREST OF THE PATIENT AND CHANGED THE BATTERY OF THE EPG. PREVIOUSLY THE LED TO INDICATE BATTERY DEPLETION HAD BEEN CONFIRMED BLINKING SEVERAL TIMES, YET THE BATTERY HAD NOT BEEN CHANGED, WHICH RESULTED IN THIS EVENT. HOWEVER, THE BLINKING DID NOT LAST FOR 24 HOURS AS IT IS SUPPOSED TO, THEREFORE A DEVICE CHECK WAS REQUESTED BY THE HOSPITAL. THE BATTERY HAD NEVER BEEN CHANGED PREVIOUSLY, BUT IT IS UNKNOWN SINCE WHEN IT HAD BEEN USED. THE EPG WAS RETURNED FOR SERVICING. THE PATIENT RECOVERED FROM CARDIAC ARREST AS THE BATTERY WAS CHANGED IMMEDIATELY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467052 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R