BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790660 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01570
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 1, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THE REPORTED EVENT. NEGATIVE BATTERY CONTACT NOT INSTALLED CORRECTLY; CONNECTION OPENS WHEN BATTERY IS INSTALLED. UPPER CASE AND BATTERY DRAWER ARE BROKEN AND CONTAMINATED WITH SUPER GLUE. MAIN SEAL AND OUTPUT CONNECTORS ARE NOT RTV (ROOM TEMPERATURE VULCANIZING) SEALED INTO THE LOWER CASE. BATTERY FLEX IS NOT ROUTED CORRECTLY. IT IS NOTED DAMAGE IS DUE TO NON MEDTRONIC PERSON DISASSEMBLING AND REASSEMBLING. LOWER CASE IS DAMAGED (NOT ENOUGH CASE TO REINSTALL BATTERY CONTACTS). BOTH BAIL COVERS ARE BROKEN. HEART BLOCK, LEAD FLEX COVER, HEART WIRE CONTACTS, AND HEART LEAD FLEX ARE CONTAMINATED WITH BLOOD. BATTERY DRAWER O-RING AND ONE CASE SCREW ARE MISSING. ONE BAIL AND RING ARE BENT. LCD (LIQUID CRYSTAL DISPLAY) GASKET IS OUT OF SPECIFICATION (LCD GASKET IS OBSTRUCTING THE VIEW OF THE LCD). ONE PRINTED CIRCUIT BOARD FLEX IS CREASED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE MANUFACTURING DATE. EVALUATION SUMMARY: (B)(4). ANALYSIS CONFIRMED THE REPORTED EVENT. NEGATIVE BATTERY CONTACT NOT INSTALLED CORRECTLY; CONNECTION OPENS WHEN BATTERY IS INSTALLED. UPPER CASE AND BATTERY DRAWER ARE BROKEN AND CONTAMINATED WITH SUPER GLUE. MAIN SEAL AND OUTPUT CONNECTORS ARE NOT RTV (ROOM TEMPERATURE VULCANIZING) SEALED INTO THE LOWER CASE. BATTERY FLEX IS NOT ROUTED CORRECTLY. IT IS NOTED DAMAGE IS DUE TO NON MEDTRONIC PERSON DISASSEMBLING AND REASSEMBLING. LOWER CASE IS DAMAGED (NOT ENOUGH CASE TO REINSTALL BATTERY CONTACTS). BOTH BAIL COVERS ARE BROKEN. HEART BLOCK, LEAD FLEX COVER, HEART WIRE CONTACTS, AND HEART LEAD FLEX ARE CONTAMINATED WITH BLOOD. BATTERY DRAWER O-RING AND ONE CASE SCREW ARE MISSING. ONE BAIL AND RING ARE BENT. LCD (LIQUID CRYSTAL DISPLAY) GASKET IS OUT OF SPECIFICATION (LCD GASKET IS OBSTRUCTING THE VIEW OF THE LCD). ONE PRINTED CIRCUIT BOARD FLEX IS CREASED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR WOULD NOT POWER ON. THE BATTERY WAS CHANGED BUT THERE WAS NO IMPROVEMENT. IT WAS FURTHER NOTED THAT THE LIQUID CRYSTAL DISPLAY (LCD) WAS DIM. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    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