BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152032 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00532
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; LOW BATTERY INDICATION IS 7.2 VOLTS NOMINAL AND END OF OPERATION IS 6.3 VOLTS NOMINAL, BATTERY RECEIVED WITH DEVICE MEASURED 6.24 VOLTS (NO LOAD). DEVICE PASSED VISUAL, ELECTRICAL AND MECHANICAL INSPECTION WITH NO ANOMALIES OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOW BATTERY INDICATOR LIGHT ON THE EXTERNAL PULSE GENERATOR DID NOT WORK. IT WAS FURTHER REPORTED THAT A PATIENT ALMOST "CODED" BECAUSE THE GENERATOR QUIT WORKING WITHOUT WARNING. THE GENERATOR WAS RETURNED FOR SERVICE. FOLLOW-UP DETERMINED THAT NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252073 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R