BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET TIP

    MDR report key: 141537 · Received March 10, 1997

    Report

    Report Number
    2649622-1997-00122
    Event Type
    Malfunction
    Date Received
    March 10, 1997
    Date of Event
    January 8, 1997
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DEVICE WITHIN SPECIFICATION - PROXIMAL SEGMENT 4/15/1997 - RESPONSE TO REQUEST FOR PAGE 2 OF 3500A.

    Description of Event or Problem · 1

    NI

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET TIP Implant IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4011 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 8427 IMPLANTABLE PULSE GENERATOR