BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951468 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00032
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE BATTERY DRAWER WAS BROKEN, THE UPPER CASE WAS BROKEN, RING COVER WAS BROKEN, AND THE RING WAS MISSING. IT WAS ALSO NOTED THAT THE BATTERY RELEASE, LEAD FLEX COVER, AND KEYBOARD PAD WERE CONTAMINATED, TWO SIDE BAIL COVERS WERE BROKEN, AND THE BATTERY CONTACTS WERE COMPRESSED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY DRAWER ON THE EXTERNAL PULSE GENERATOR WOULD NOT CLOSE, ALSO THAT THE GENERATOR HAD A CRACKED UPPER CASE AND THE RING AND RING COVER WERE MISSING. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD A BATTERY DOOR THAT WOULD NOT CLOSE. ALSO NOTED WAS THE RING HAD BROKEN OFF AS WELL. TECHNICAL SERVICES SUGGESTED THAT THE EPG BE SENT IN FOR REPAIR. THE STATUS OF THE EPG IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56009 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1