BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A&E MEDICAL CORPORATION DISPOSABLE MYO LEAD (DML)

    MDR report key: 6785997 · Received August 10, 2017

    Report

    Report Number
    2242056-2017-00002
    Event Type
    Malfunction
    Date Received
    August 10, 2017
    Date of Event
    July 12, 2017
    Report Date
    August 10, 2017
    Manufacturer
    ALTO DEVELOPMENT CORPORATION
    Product Code
    IKD
    UDI-DI
    10841291105282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: DEVICE IS AN "EXEMPT" DEVICE. COMPLAINT WAS RECEIVED BY DISTRIBUTOR (B)(4) VIA (B)(6) HOSPITAL (B)(6). RETURNED DEVICE WAS RECEIVED ON 7/17/2017. THE RETURNED DEVICE HAS BEEN SENT OUT FOR STERILIZATION AS PART OF THE A AND E MEDICAL DECONTAMINATION PROCESS. DEVICE HAS NOT RETURNED IN TIME FOR INITIAL FILING. A FOLLOW UP REPORT WILL BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    NOTE: DEVICE IS AN "EXEMPT" DEVICE. COMPLAINT WAS RECEIVED BY DISTRIBUTOR ANCLOTE SURGICAL (MR. (B)(6)) VIA (B)(6) HOSPITAL (MS. (B)(6)). RETURNED DEVICE WAS RECEIVED ON 7/17/17. THE RETURNED DEVICE HAS BEEN SENT OUT FOR STERILIZATION AS PART OF THE A&E MEDICAL DECONTAMINATION PROCESS. DEVICE HAS NOT RETURNED IN TIME FOR INITIAL FILING. A FOLLOW UP REPORT WILL BE CONDUCTED. RETURNED DEVICE HAS BEEN INVESTIGATED AND IS INCLUDED AS PART OF THE FOLLOW UP REPORT. [(B)(4)].

    Description of Event or Problem · 1

    PHONE CALL WAS RECEIVED ON 7/12/2017 FROM DISTRIBUTOR OF DEVICE ((B)(4)) REPORTING COMPLAINT RECEIVED FROM DIRECTOR OF CARDIAC SURGERY AT (B)(6) HOSPITAL (B)(6) PERTAINING TO A PATIENT CABLE (DISPOSABLE MYO LEAD), PART NUMBER 019-540, LOT UNKNOWN. THE COMPLAINT REPORTS THE DEVICE DID NOT FUNCTION ELECTRONICALLY AND WOULD NOT PACE THE PATIENT.

    Description of Event or Problem · 1

    PHONE CALL WAS RECEIVED ON 7/12/2017 FROM DISTRIBUTOR OF DEVICE ((B)(6)) REPORTING COMPLAINT RECEIVED FROM DIRECTOR OF CARDIAC SURGERY AT (B)(6) HOSPITAL SOUTH ((B)(6)) PERTAINING TO A PATIENT CABLE (DISPOSABLE MYO LEAD), PART NUMBER 019-540, LOT UNKNOWN. THE COMPLAINT REPORTS THE DEVICE DID NOT FUNCTION ELECTRONICALLY AND WOULD NOT PACE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565560 A&E MEDICAL CORPORATION DISPOSABLE MYO LEAD (DML) PATIENT CABLE IKD ALTO DEVELOPMENT CORPORATION 019-540 UNKNOWN 10841291105282

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention