BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC CORP

    MDR report key: 196903 · Received November 5, 1998

    Report

    Report Number
    MW1014952
    Event Type
    Injury
    Date Received
    November 5, 1998
    Date of Event
    February 25, 1998
    Report Date
    November 5, 1998
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    MAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEART ATTACK ON 2-25-98. THREE STENTS IMPLANTED WITH DIFFICULTY, USING RANGER DURING ANGIOPLASTY. SEVERE HEART ATTACK ON 4-24-98. DOCTORS ALL SAY CAUSED BY DISTORTED STENT, FLOATED AND BLOCKED ARTERY. HAD TO DELAY SURGERY 3 DAYS DUE TO HEAVY BLOOD IN URINE. HAD ALL THE SYMPTOMS OF RECALL OF RANGER BY BOSTON SCIENTIFIC. WAS IN HOSP REHAB 4 TIMES, 4 DAYS, APRIL-AUGUST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORP Implant RANGER CORONARY STENT DELIVERY SYSTEM MAF BOSTON SCIENTIFIC CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R