BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 6005788 · Received October 6, 2016

    Report

    Report Number
    3004209178-2016-20710
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    August 17, 2016
    Report Date
    August 17, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER); 3,061,352 ATRIAL-SIC OCCURRED SINCE (B)(4) 2016.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS CONFIRMED THE REPORTED CONDITION WITH THE DEVICE SHOWING ATRIAL OVER SENSING WHEN IT WAS PROGRAMMED TO BIPOLAR MODE AND DIFFERENT PARAMETERS. HOWEVER, AFTER THE DEVICE WAS OPENED, THE FAILURE MODE DISAPPEARED AND COULD NOT BE REESTABLISHED. THIS DEVICE WAS RETURNED AFTER 14 MONTHS DUE TO ATRIAL OVERSENSING. THE REPORTED CONDITION WAS CONFIRMED BY THE RETURNED PRODUCT ANALYSIS LABORATORY (RPA). THE (B)(6) CONFIRMED THE REPORTED CONDITION. THE DEVICE SHOWED NO SENSING WHEN IT WAS PROGRAMMED TO UNIPOLAR AND OVERSENSING WHEN THE DEVICE WAS TESTED USING THE VIRTUAL INTERACTIVE PATIENT (VIP-II) SIMULATOR. AFTER THE DEVICE WAS OPENED, THE DEVICE WAS TESTED AGAIN USING THE VIP-II HOWEVER THE DEVICE WAS FULLY FUNCTIONAL. THE REGULATED SUPPLY AND REFERENCES VOLTAGES WERE MEASURED. ALL WERE AT THEIR INTENDED LEVELS. THE HYBRID WAS THEN PLACED IN A TEMPERATURE CHAMBER AT 60°C AND WAS MONITORING FOR 72 HOURS. HOWEVER, THE DEVICE REMAINED FUNCTIONAL. VISUAL INSPECTION OF THE STACKED CHIP SCALE PACKAGE (SCSP) REVEALED CONTAMINATION ACROSS SOME TRACES. BECAUSE OF THIS, A MOR E DETAILED INSPECTION WAS PERFORMED USING A SCANNING ELECTRON MICROSCOPE (SEM) WHERE EVIDENCE OF A FOREIGN MATERIAL KNOWN AS MUD CRACK RESIDUE (MCR) WAS OBSERVED ACROSS SEVERAL PADS. AN ELECTRICAL SHORT CONSISTENT WITH THE LOCATION OF OBSERVED MCR WAS SIMULATED ON A SYSTEM BREADBOARD; HOWEVER, IT DID NOT CAUSE THE ATRIAL OVERSENSING. THEREFORE THE REPORTED FAILURE COULD NOT BE ATTRIBUTED TO THESE ANOMALIES. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    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 IMPLANTABLE PULSE GENERATOR (IPG) DEVICE EXHIBITED ELECTRO-MAGNETIC INTERFERENCE (EMI) DURING RADIOTHERAPY. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED THAT THERE WAS SUSPECTED RADIATION DAMAGE TO THE IPG DEVICE. THE DEVICE EXHIBITED ATRIAL OVERSENSING AT A NON-PHYSIOLOGIC RATE. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660027 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. A2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R