BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 2813601 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02541
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. A WRITE TO LOCKED RAM POWER ON RESET (POR) OCCURRED ON (B)(6) 2012. THIS POR OCCURRED AFTER DEVICE WAS EXPLANTED.

    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) WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY DEPLETION WAS INDICATED/ERI. TIME OF ERI IN SAVE TO DISK WAS ON (B)(6) 2012 WITH DEVICE ERI <=2.62 VOLT. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN B(V)=2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2012. TWO PATIENT ALERTS FOR LOW BATTERY VOLTAGE OCCURRED ON (B)(6) 2012, 03:00:05 AND (B)(6) 2012, 03:00:05.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT SOUNDED AND WHEN THE PATIENT WAS CHECKED TWO WEEKS LATER THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND HAD PROLONGED CHARGE TIME. WHEN THE DEVICE WAS SUBSEQUENTLY REPLACED IT WAS QUESTIONED WHY THE DEVICE WAS AT END OF LIFE (EOL) LESS THAN THREE MONTHS AFTER ERI. DURING THE REPLACEMENT PROCEDURE IT WAS NOTED THAT CHARGE TIME WAS BELOW TEN SECONDS. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATION HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD