BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9301

    MDR report key: 9301 · Received July 29, 1994

    Report

    Report Number
    9301
    Event Type
    Injury
    Date Received
    July 29, 1994
    Date of Event
    February 10, 1994
    Report Date
    July 19, 1994
    Manufacturer
    UNKNOWN
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PLEASE BE ADVISED THAT ON 2/10/94, A 78 YEAR OLD MALE WITH PERMANENT PACEMAKER UNDERWENT SURGERY FOR PARTIAL REMOVAL OF MALFUNCTIONING VENTRICULAR PACER LEAD, MODEL 4004 #LAZ 045989 AND PLACEMENT OF NEW VENTRICULAR LEAD MODEL 5024M 52 CM #LAT 062662 V. THE PATIENT TOLERATED THE PROCEDURE WELL.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER 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 DTB UNKNOWN 4004

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention