BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2013-07351

    MDR report key: 3092757 · Received May 3, 2013

    Report

    Report Number
    2124215-2013-07351
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PHYSICIAN MENTIONED TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) THAT THEY HAD A DEVICE DISPLAY AN EXTENDED CHARGE TIME. TS DISCUSSED SVO BATTERY CHEMISTRY WITH THE PHYSICIAN. THE PHYSICIAN DID NOT PROVIDE PATIENT OR MODEL/SERIAL NUMBER SPECIFIC INFORMATION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193837 LWS GUIDANT PUERTO RICO BV TACHY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 030-247| 1010| 0950| 4285| 1283| 0465