BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152209 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00514
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT OF NO OUTPUT. ANALYSIS DID FIND THAT THE LOWER CASE AND THE BATTERY DRAWER WERE BROKEN, SO THEY WERE REPLACED, ONE KNOB, RING COVER AND RING BAIL WERE MISSING SO THEY WERE REPLACED, THAT THE BATTERY CONTACTS WERE COMPRESSED, SO THEY WERE REPLACED, THE KEYBOARD WAS SCRATCHED SO IT WAS REPLACED AND THAT IT NEEDED A BATTERY DRAWER O-RING. (B)(4).

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD NO OUTPUT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. NO PATIENT IMPACT WAS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD NO OUTPUT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. NOPATIENT IMPACT WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252353 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1