BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3989883 · Received August 7, 2014

    Report

    Report Number
    9614453-2014-01838
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 28, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ANALYSIS DETERMINED THAT THE STUCK-IN-UNIPOLAR PACING MODE CONDITION WAS CAUSED BY A FOREIGN MATERIAL (FM) SHORTING THE BATTERY CASE TO THE DEVICE CAN. THIS FM ALSO CAUSED THE LEAD IMPEDANCE MEASUREMENT TO BE INHIBITED AND DEPLETED THE BATTERY. THE FM WAS IDENTIFIED AS A SECTION OF LASER RIBBON BOND (LRB) THAT HAD PREVIOUSLY BEEN ATTACHED TO THE RIGHT VENTRICULAR TIP BOND PAD ARRAY (BPA) OF THE HYBRID.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, WHEN THE LEADS WERE CONNECTED TO THE DEVICE PACING WAS INHIBITED. THE LEADS WERE TESTED VIA THE ANALYZER AND FOUND TO BE OK. WHEN CONNECTED TO THE DEVICE AGAIN, THERE WAS INTERMITTENT INHIBITION ESPECIALLY DURING MANIPULATION. BIPOLAR PACING WAS SEEN WHEN THE DEVICE WAS OUTSIDE THE BODY, BUT WHEN INSIDE IT LOOKED LIKE UNIPOLAR PACING WITH BIG ARTIFACTS. THE DEVICE WAS ALSO UNABLE TO MEASURE IMPEDANCE. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465129 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1