BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMOND 3

    MDR report key: 1924547 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06150
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S4
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    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) DEVICE ANALYSIS FOUND NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A VERY SHORT END OF LIFE EXPECTANCY. THE BATTERY IMPEDANCE HAD MEASURED 8,600 OHMS DURING A DEVICE CHECK AND ONE WEEK LATER THE BATTERY IMPEDANCE MEASURED 17,600 OHMS. THE PHYSICIAN FELT THIS CREATED A DANGEROUS SITUATION BECAUSE THE PATIENT WAS PACEMAKER DEPENDENT. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND 3 IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 840 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R