BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSSIS SUTURELESS MYOCARDIAL LEAD

    MDR report key: 8411 · Received February 17, 1994

    Report

    Report Number
    2124215-1993-00009
    Event Type
    Injury
    Date Received
    February 17, 1994
    Date of Event
    January 24, 1994
    Report Date
    January 25, 1994
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    DTD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR RECEIVED INFORMATION THAT A PT WITH AN AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD), (WHICH IS UNDER CLINICAL INVESTIGATION), AND TWO MYOCARDIAL LEADS, EXHIBITED OVERSENSING WITH MANIPULATION OAF THE POCKET. THE PHYSICIAN PERFORMED AN INVASIVE PROCEDURE TO EVALUATE THE SYSTEM AND COULD NOT REPRODUCE THE PROBLEM, HOWEVER, THE PHYSICIAN ELECTED TO REMOVE THE LEAADS FROM SERVICE.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSSIS SUTURELESS MYOCARDIAL LEAD Implant LEAD DTD POSSIS MEDICAL, INC. 4320

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention