BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSSIS SUTURELESS MYOCARDIAL LEAD

    MDR report key: 29121 · Received December 4, 1995

    Report

    Report Number
    2124215-1995-00111
    Event Type
    Injury
    Date Received
    December 4, 1995
    Date of Event
    February 4, 1994
    Report Date
    November 30, 1995
    Manufacturer
    POSSIS MEDICAL INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CO'S LEGAL DEPT RECEIVED INFO THAT A PT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND TWO MYOCARDIAL RATE SENSING LEADS WAS EXPERIENCING OVERSENSING/INAPPROPRIATE THERAPY. INVASIVE ANALYSIS IDENTIFIED AN INSULATION PROBLEM WITH THE MYOCARDIAL LEADS (4320-020965 & 4320-020966). THE PAPERWORK RECEIVED DID NOT IDENTIFY WHICH LEAD HAD THE PROBLEM. THE LEADS WERE CAPPED AND A NEW ENDOCARDIAL LEAD AND ICD WERE IMPLANTED. IMPLANTED-4/13/93. EXPLANTED-2/4/94 (IMPLANTED TIME-9 MONTHS).DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. 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 LWS POSSIS MEDICAL INC. 4320 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention