BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II DR

    MDR report key: 2811609 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06092
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    Z-0113-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) - THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. STD REVIEW - WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD INTERMITTENT, STEADY TONES COMING FROM THE DEVICE. WHEN THE DEVICE WAS INTERROGATED THE "SUSPEND" WINDOW POPPED OPEN. THERE WERE NO SOURCES OF MAGNETS OR OTHER ELECTRICAL INTERFERENCE AROUND; INCLUDING ON THE PATIENT'S CLOTHES OR ANYTHING THAT THEY HAD CONSUMED FOR LUNCH. THE PATIENT REFUSED TO GO TO THE HOSPITAL. THE PATIENT WAS MADE AWARE THAT THERAPY MAY NOT BE DELIVERED. THE PATIENT WAS SUBSEQUENTLY SEEN IN THE EMERGENCY ROOM AFTER HEARING THE TONES AGAIN. 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
    1 MAXIMO II DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D284DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| L| R 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD