BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152233 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00513
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    EVALUATION SUMMARY: THE GENERATOR WAS RETURNED AND ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT THAT IT WOULD INTERMITTENTLY SHUT OFF DURING THE POWER-UP BOOT CYCLE. ANALYSIS DID FIND THAT THE UPPER CASE WAS BROKEN, THE LOWER CASE WAS CORRODED, BROKEN AND CONTAMINATED, THE BATTERY RELEASE, BATTERY DRAWER AND BATTERY DRAWER O-RING WERE CONTAMINATED, THE SIDE BAIL COVERS, RING COVER, SIDE BAILS AND RING BAIL WERE MISSING, THAT THE LEAD FLEX COVER WAS CORRODED AND BROKEN, THE BATTERY CONTACTS WERE COMPRESSED AND CONTAMINATED AND THE BATTERY FLEX WAS CORRODED AND CONTAMINATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE EXTERNAL PULSE GENERATOR (EPG) WILL INTERMITTENTLY SHUT OFF DURING THE POWER-UP BOOT CYCLE. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EXTERNAL PULSE GENERATOR (EPG) WILL INTERMITTENTLY SHUT OFF DURING THE POWER-UP BOOT CYCLE. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252398 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1