BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3158771 · Received June 10, 2013

    Report

    Report Number
    2183613-2013-00772
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BIOMEDICAL ENGINEER WAS USING THE SIGMA PACE 100 TO TEST THE OFF CURRENT DRAIN AND FOUND THAT THE OFF CURRENT DRAIN ON THE EXTERNAL PULSE GENERATOR (EPG) WAS OUT OF SPECIFICATION. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR SERVICE. IT WAS SUBSEQUENTLY RETURNED FROM SERVICE WITH A SERVICE REPORT STATING THAT THE OFF CURRENT DRAIN WAS FOUND TO BE OKAY. THE STATUS OF THE EPG IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT. FOLLOW-UP WITH THE CUSTOMER FOUND THAT THE BIOMEDICAL ENGINEER HAD BEEN USING THE WRONG SPECIFICATION. THE CUSTOMER NOTED THAT THE EVENT DESCRIPTION SHOULD HAVE BEEN ON CURRENT DRAIN WITH BACK LIGHT OFF TESTED OUT OF SPECIFICATION. A CHECK OUT MANUAL WAS SENT, WHICH HAD THE SPECIFICATIONS FOR THE TESTS IN QUESTION, AND THE EPG REMAINS WITH THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BIOMEDICAL ENGINEER WAS USING THE SIGMA PACE 100 TO TEST THE OFF CURRENT DRAIN AND FOUND THAT THE OFF CURRENT DRAIN ON THE EXTERNAL PULSE GENERATOR (EPG) WAS OUT OF SPECIFICATION. THE SERVICE REPORT STATED THAT THE OFF CURRENT DRAIN WAS OKAY. THE STATUS OF THE EPG IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261220 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1