BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM VR

    MDR report key: 1992604 · Received February 15, 2011

    Report

    Report Number
    2647346-2011-00173
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    October 27, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P900061/S35
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE LOST TELEMETRY AND FUNCTION DUE TO BATTERY DEPLETION. THERE WAS NO COMPLAINT OF TELEMETRY LOSS AND NO MENTION OF TELEMETRY LOSS IN THE DOCUMENTATION RECEIVED WITH THE DEVICE. FOR THIS REASON IT IS ASSUMED THE LOSS OF TELEMETRY OCCURRED BETWEEN EXPLANT AND RECEIPT AT THE ANALYSIS LAB. THE CAUSE OF THE DEPLETION CANNOT BE DETERMINED. THERE IS NO MENTION OF BATTERY VOLTAGE LEVEL AT EXPLANT AND NONE COULD BE RETRIEVED IN ANALYSIS. THE DEVICE WAS FULLY FUNCTIONAL AND OPERATED UNDER NORMAL CURRENT DRAIN WHEN POWERED WITH AN EXTERNAL SUPPLY. THE RESIDUAL VOLTAGE AND IMPEDANCE INDICATES THAT THE BATTERY WAS NOT INTERNALLY SHORTED. THE EXPECTED LONGEVITY PER THE MODELS TABLE IS ABOUT 38 MONTHS LESS THAN THE AMOUNT OF TIME THE DEVICE WAS IMPLANTED. SINCE NO SAVE TO DISK DATA COULD BE RETRIEVED FROM THE DEVICE AND NO OTHER DATA WAS PROVIDED FROM THE FIELD THERE IS NO WAY TO CONFIRM THIS RESULT. THE RESULT OF ANALYSIS IS INCONCLUSIVE.

    Description of Event or Problem · 1

    PATIENT INDICATES ALARM WENT OFF AND IT WAS DESCRIBED AS A "GLITCH." ALARM SETTING SET AT 14 ORIGINALLY IS GRADUALLY DROPPING. THE DEVICE WAS EXPLANTED, RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7227CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R 6944 IMPLANTABLE TACHY LEAD