BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM III DR

    MDR report key: 2201740 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01336
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 15, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S14
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY : (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SINUS TACHYCARDIA, THE DEVICE DELIVERED THERAPY, AND THE RHYTHM PROGRESSED TO VENTRICULAR TACHYCARDIA WHERE THE PATIENT RECEIVED ADDITIONAL SHOCKS. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING THE SHOCKS, WHERE THE DEVICE WAS INTERROGATED AND A CHARGE CIRCUIT TIMEOUT WAS OBSERVED. THE BATTERY VOLTAGE WAS LOW AND THE DEVICE WAS AT END OF SERVICE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM III DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7275 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD