BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152222 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00512
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 CONFIRMED THE CUSTOMER COMMENT THAT THE UPPER AND LOWER CASES WERE BROKEN, BUT COULD NOT CONFIRM THE CUSTOMER COMMENT THAT IT WAS UNABLE TO CAPTURE AS THE DEVICE WOULD NO LONGER POWER UP. ANALYSIS ALSO FOUND THE LOWER CASES, THE BATTERY RELEASE AND THE LEAD FLEX COVER WERE CONTAMINATED, THAT BOTH BAIL COVERS, THE RING COVER, TWO CASE SCREWS, BOTH BAILS, THE BATTERY DRAWER O-RING AND THE RING WERE MISSING, THE BATTERY CONTACTS WERE COMPRESSED, THE KEYBOARD WAS SCRATCHED, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF SPECIFICATION, THE BATTERY FLEX AND THE HEART LEAD FLEX WERE CORRODED AND THE SERIAL NUMBER LABEL WAS DAMAGED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) "WOULD NOT CAPTURE PATIENT." THE EPG WAS REPLACED, AND USING THE SAME SETTING, EVERYTHING WORKED. IT WAS FURTHER REPORTED THE EPG HAD A CRACKED CASE, DUE TO IT BEING DROPPED. 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 THAT THE EXTERNAL PULSE GENERATOR (EPG) "WOULD NOT CAPTURE PATIENT." THE EPG WAS REPLACED, AND USING THE SAME SETTING, EVERYTHING WORKED. IT WAS FURTHER REPORTED THE EPG HAD A CRACKED CASE, DUE TO IT BEING DROPPED. 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
    252847 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention