BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM

    MDR report key: 6465201 · Received April 6, 2017

    Report

    Report Number
    2124215-2017-04500
    Event Type
    Malfunction
    Date Received
    April 6, 2017
    Date of Event
    July 8, 1991
    Report Date
    August 27, 2020
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL REPORT WAS ORIGINALLY SUBMITTED IN 1991 WITH OLD NUMBERING STYLE OF #M240753. THIS REPLACEMENT MDR IS TO LINK THE SUPPLEMENTAL REPORT SENT ON MDR #2124215-2017-04500. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE BATTERY STATUS COULD NOT BE OBTAINED. VISUAL INSPECTION NOTED BOTH SETSCREWS WERE MISSING. USING AN RX5000 PROGRAMMER, AN INITIAL INTERROGATION NOTED THAT THE DEVICE WOULD NOT COMMUNICATE. PACING AND SENSING TESTING WAS UNABLE TO BE PERFORMED DUE TO THE LOW BATTERY VOLTAGE. RECORDS SHOW AN IMPLANT DATE OF (B)(6) 1983 AND AN EXPLANT DATE OF (B)(6) 1993 AND AN EVENT DATE OF (B)(6) 1991. THIS SUGGESTS THE DEVICE WAS IMPLANTED FOR 7.6 YEARS WHEN THIS REPORT WAS ORIGINALLY FILED. BASED ON THE IMPLANT AND EXPLANT DATES, THE DEVICE WOULD HAVE BEEN IN SERVICE FOR OVER 9.8 YEARS. THE NOMINAL LONGEVITY FOR THIS MODEL DEVICE IS 7.5 YEARS. THE FIELD OBSERVATIONS OF A SENSING OR DETECTION PROBLEM WERE NOT CONFIRMED.

    Description of Event or Problem · 1

    THIS INITIAL REPORT WAS ORIGINALLY SUBMITTED IN 1991 WITH OLD NUMBERING STYLE OF #M240753. THIS REPLACEMENT MDR IS TO LINK THE SUPPLEMENTAL REPORT SENT ON MDR #2124215-2017-04500. A REPORT WAS FILED IN 1991 FOR A SENSING OR DETECTION PROBLEM. THE DEVICE WAS RETURNED 26 YEARS LATER WITH NO CORRESPONDING ALLEGATION OR CLINICAL EVENT AND WAS ANALYZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252643 QUANTUM IMPLANTABLE DEVICE LWP BOSTON SCIENTIFIC 254-10

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male