BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SBP DR INDUCTIVE PACEMAKER, JPD

    MDR report key: 6392793 · Received March 9, 2017

    Report

    Report Number
    2017865-2017-01624
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    December 27, 2016
    Report Date
    April 26, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS COULD NOT DETERMINE THE CAUSE OF THE REPORTED ANOMALIES. NORMAL DEVICE FUNCTION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN THE LEADS WERE CONNECTED TO THE PULSE GENERATOR (7824073) THE DEVICE EXHIBITED A LOSS OF OUTPUT AND HIGH IMPEDANCE MEASUREMENTS. THE PHYSICIAN ELECTED TO NO LONGER USE AND REPLACE THE DEVICE. THE SECOND DEVICE (7823645) WAS USED BUT THE SAME ANOMALIES WERE NOTED. THE DEVICE WAS NO LONGER USED AND REPLACED SUCCESSFULLY. THE PATIENT WAS IN STABLE CONDITION POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176393 SBP DR INDUCTIVE PACEMAKER, JPD IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2152 A000028267

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)