BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 4140008 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17251
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 2, 2014
    Report Date
    December 15, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, COMMUNICATION WITH THE DEVICE COULD NOT BE ESTABLISHED AND NO TONES WERE PRESENT WITH MAGNET APPLICATION. EXAMINATION OF THE DEVICE FLEX HYBRID NOTED THAT THERE WAS SOME DAMAGE INDUCED WHEN A CAP STACK WAS CUT OFF. THE DEVICE WAS FOUND TO HAVE HIGH CURRENT ON THE SUPPLY CIRCUIT, WHICH WAS ISOLATED, BUT DUE TO INDUCED DAMAGE DURING ANALYSIS, WAS UNABLE TO BE PINPOINTED. THIS CAUSED A HIGH CURRENT DRAIN THAT RESULTED IN PREMATURE BATTERY DEPLETION WHICH RESULTED IN THE NO INTERROGATION CONDITION SEEN. NO FURTHER ANALYSIS COULD BE PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS UNSUCCESSFULLY INTERROGATED FOLLOWING SEVERAL TROUBLESHOOTING ATTEMPTS. A DEVICE CHANGE OUT PROCEDURE WAS SCHEDULED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620654 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 5076| E110| 6947| 1861