BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952914 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00162
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: AFTER THE DEVICE WAS RETURNED A SECOND TIME FOR THE SAME ISSUE, SERVICING AND REPAIR OF THE DEVICE FOUND THAT THE MAIN PCB WAS OUT OF ELECTRICAL SPECIFICATION. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, CORRODED AND CONTAMINATED, THE BATTERY RELEASE AND BATTERY DRAWER WERE CONTAMINATED, THE SIDE BAIL COVERS WERE BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, THE LEAD FLEX COVER WAS CORRODED, THE KEYBOARD WAS SCRATCHED, THE BATTERY FLEX WAS CORRODED, THE BATTERY DRAWER O-RING WAS MISSING, AND THE DISPLAY WAS MISSING PIXEL SEGMENTS.

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; MAIN PRINTED CIRCUIT BOARD (PCB) OUT OF ELECTRICAL SPECIFICATION. ANALYSIS ALSO FOUND UPPER AND LOWER CASES ARE BROKEN, CORRODED AND CONTAMINATED, BATTERY RELEASE IS CONTAMINATED, BOTH BAIL COVERS ARE BROKEN, LEAD FLEX COVER IS CORRODED, BATTERY CONTACTS ARE COMPRESSED, BATTERY DRAWER IS CONTAMINATED, KEYBOARD IS SCRATCHED, MAIN PCB IS CORRODED, AND BATTERY DRAWER O-RING IS MISSING. IT IS NOTED THERE IS EVIDENCE OF DEVICE TAMPERING AS THE LCD (LIQUID CRYSTAL DISPLAY) IS DAMAGED AND THERE IS EXTRA ADHESIVE ON THE VENTRICLE OUTPUT CONNECTOR. BATTERY RECEIVED WITH DEVICE MEASURED 8.05 VOLTS (NO LOAD).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) DID NOT PACE FOR THE MINIMUM 15 SECONDS PROGRAMMED WHEN THE BATTERY DRAWER WAS OPENED AND THE BATTERY REMOVED. THE EPG WILL BE RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE EPG WAS RETURNED FOR REPAIR.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE GENERATOR WAS RETURNED FOR SERVICE FOR THE EXACT SAME COMPLAINT, AS IT HAD BEEN RETURNED TO THE CUSTOMER UNREPAIRED DUE TO EXTENSIVE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56650 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1