BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790689 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01676
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    June 15, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4). ENCODER FLEX IS OUT OF SPECIFICATION (FLEXES WERE MISALIGNED); PINS FROM THE FLEX CONNECTOR WERE BARELY MAKING CONTACT. UPPER AND LOWER CASES, SIDE BAIL COVERS, RING COVER, AND BATTERY DRAWER ARE BROKEN. BATTERY RELEASE AND HEART BLOCK ARE CONTAMINATED. BATTERY CONTACTS ARE COMPRESSED. BATTERY DRAWER O-RING IS MISSING. ONE KNOB IS MISSING.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4). ENCODER FLEX IS OUT OF SPECIFICATION (FLEXES WERE MISALIGNED); PINS FROM THE FLEX CONNECTOR WERE BARELY MAKING CONTACT. UPPER AND LOWER CASES, SIDE BAIL COVERS, RING COVER, AND BATTERY DRAWER ARE BROKEN. BATTERY RELEASE AND HEART BLOCK ARE CONTAMINATED. BATTERY CONTACTS ARE COMPRESSED. BATTERY DRAWER O-RING IS MISSING. ONE KNOB IS MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE EPG (EXTERNAL PULSE GENERATOR) LOOKS TO HAVE BEEN DROPPED. EPG HAS A DAMAGED CASE AND MISSING KNOB. THE EPG WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other