BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952361 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00100
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE UNIT WOULD NOT TURN ON. ANALYSIS DID FIND THE LIQUID CRYSTAL DISPLAY (LCD) OUT OF SPECIFICATION, THE UPPER AND LOWER CASES BROKEN, TWO SIDE BAIL COVERS BROKEN, THE BATTERY CONTACTS COMPRESSED, THE BATTERY RELEASE AND LEAD FLEX COVER CONTAMINATED AND THE BATTERY DRAWER BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EXTERNAL PULSE GENERATOR (EPG) WILL NOT POWER ON EVEN WITH A NEW 9 VOLT BATTERY. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EXTERNAL PULSE GENERATOR (EPG) WILL NOT POWER ON EVEN WITH A NEW 9 VOLT BATTERY. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57382 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1