BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II VR

    MDR report key: 2953516 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00245
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    February 28, 2012
    Report Date
    December 3, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE ANALYSIS OF THE HYBRID INITIALLY DOCUMENTED HIGH DEVICE CURRENT DRAIN FOR A BRIEF PERIOD OF TIME. THEN THE FAILURE CONDITION CLEARED AND NOMINAL CURRENT DRAIN IN BOTH POR PACING PARAMETERS WITH NO PACING LOADS AND DDD PACING WITH THE OUTPUT CHAMBERS LOADED WAS OBSERVED FOR THE REMAINDER OF THE ANALYSIS. THE REPORTED INAPPROPRIATE SHOCK FAILURE CONDITION WAS NOT CONFIRMED, AS NO FALSE SENSING EVENTS WERE OBSERVED. DEVICE TELEMETRY AND OUTPUT FUNCTIONED NOMINALLY AFTER THE HIGH CURRENT DRAIN FAILURE CLEARED. ALSO, NOMINAL LEVELS WERE MEASURED FOR THE DEVICE REFERENCE VOLTAGES. A VISUAL INSPECTION OF THE EXPOSED COPPER TRACES ALONG THE SMALL CHIP SCALE PACKAGE (SCSP) EDGES DOCUMENTED MULTIPLE METAL ANOMALIES BETWEEN THE TRACE TERMINATIONS. SIMULATIONS OF THE OBSERVED METAL ANOMALIES RESULTED IN HIGH CURRENT DRAIN AND OVERSENSING IN THE RIGHT VENTRICULAR CHAMBER. THESE FAILURE CONDITIONS ARE CONSISTENT WITH THE OBSERVED DEPLETED BATTERY AND THE REPORTED INAPPROPRIATE SHOCK FAILURE MODES. THE ANALYSIS WAS STOPPED WITH THE ELECTRICAL FAILURE CONDITIONS CLEARED, BUT ATTRIBUTABLE TO THE METAL ANOMALIES OBSERVED ON THE SCSP. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND THE DEVICE IS PRE/APPROACHING ELECTIVE REPLACEMENT INDICATOR (ERI). DAILY BATTERY VOLTAGE TREND DATA SHOWS A ONE DAY SPIKE DECREASE IN BATTERY VOLTAGE OF 1.75 TO 3.12 VOLTS RANGE BETWEEN (B)(6) 2012. INTERFERENCE/NOISE: VENTRICULAR SHORT INTERVAL COUNT V-SIC OF 16334 COUNTS, IN 1.65 DAYS, OCCURRED FROM (B)(6) 2012 23:14:36 TO (B)(6) 2012 14:45:09. A LEAD INTEGRITY ALERT TRIGGERED. ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR OCCURRED ON (B)(6) 2012 09:17:20. HIGH RESISTANCE/IMPEDANCE: ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2012 09:00:11. PROGRAMMER DATA SHOWS ONE ALERT EVENT "RV PACING LEAD IMPEDANCE > 3000 OHMS" ON (B)(6) 2012 09:00:11. LOW RESISTANCE/IMPEDANCE: ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2012 15:00:11. PROGRAMMER DATA SHOWS ONE ALERT EVENT "RV PACING LEAD IMPEDANCE 0 OHMS" ON (B)(6) 2012 15:00:11. OVERSENSING: 14-VENTRICULAR NONSUSTAINED TACHYCARDIA EPISODES OF LESS THAN OR EQUAL TO 210 MS OCCURRED FROM (B)(6) 2012 14:21:42 TO 14:23:08. 16 VENTRICULAR FIBRILLATION (VF) EPISODES OF LESS THAN 210 MS AVERAGE V-CYCLE OCCURRED BETWEEN (B)(6) 2012 02:39:04 AND (B)(6) 2012 14:23:17.

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS. THERE WAS AN RV LEAD WARNING FOR HIGH IMPEDANCE. THE SENSITIVITY WAS DECREASED AND THE PATIENT SUBSEQUENTLY RECEIVED A SHOCK. THE FOLLOWING DAY THE RV PACING IMPEDANCE WAS ZERO, AND THE HIGH VOLTAGE COIL IMPEDANCE WAS HIGH. IN ADDITION, THE BATTERY VOLTAGE WENT TO 1.75 V WITH NO ELECTIVE REPLACEMENT INDICATOR (ERI) OR END OF LIFE (EOL) REPORTED, AND IT WAS NOT POSSIBLE TO INTERROGATE THE LAST TWO SHOCK EPISODES. THERE WAS ALSO OVERSENSING, AND IT WAS SUSPECTED THE DEVICE HAD A SHORT CIRCUIT. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57331 MAXIMO II VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D284VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R