BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790408 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01608
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 16, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE MANUFACTURING DATE. EVALUATION SUMMARY: (B)(4). ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. UPPER AND LOWER CASES, RING COVER, AND TWO SIDE BAIL COVERS ARE BROKEN. BATTERY RELEASE, LEAD FLEX COVER, BATTERY DRAWER, AND KEYBOARD PAD ARE CONTAMINATED. MAIN PRINTED CIRCUIT BOARD ASSEMBLY IS OUT OF SPECIFICATION (COMPONENT MISSING ON THE BOARD). THE RING IS BENT. BATTERY CONTACTS ARE COMPRESSED.

    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 COULD NOT CONFIRM THE REPORTED EVENT. UPPER AND LOWER CASES, RING COVER, AND TWO SIDE BAIL COVERS ARE BROKEN. BATTERY RELEASE, LEAD FLEX COVER, BATTERY DRAWER, AND KEYBOARD PAD ARE CONTAMINATED. MAIN PRINTED CIRCUIT BOARD ASSEMBLY IS OUT OF SPECIFICATION (COMPONENT MISSING ON THE BOARD). THE RING IS BENT. BATTERY CONTACTS ARE COMPRESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR POWERED ON ONLY INTERMITTENTLY, THAT SOMETIMES IT WOULD BEGIN TO POWER ON BUT THEN JUST SHUT OFF, AND OTHER TIMES WAS ABLE TO POWER ON CORRECTLY. IT WAS FURTHER NOTED THAT THE BATTERY SWAP RUN TIME WAS APPROXIMATELY 20 SECONDS AND THAT PHYSICAL CASE DAMAGE WAS NOTED. THE GENERATOR WAS RETURNED FOR SERVICE. THIS WAS DISCOVERED DURING ROUTINE BIOMEDICAL TESTING AND THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR POWERED ON ONLY INTERMITTENTLY, THAT SOMETIMES IT WOULD BEGIN TO POWER ON BUT THEN JUST SHUT OFF, AND OTHER TIMES WAS ABLE TO POWER ON CORRECTLY. IT WAS FURTHER NOTED THAT THE BATTERY SWAP RUN TIME WAS APPROXIMATELY 20 SECONDS AND THAT PHYSICAL CASE DAMAGE WAS NOTED. THE GENERATOR WAS RETURNED FOR SERVICE. THIS WAS DISCOVERED DURING ROUTINE BIOMEDICAL TESTING AND 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