Events

Retiro De Equipo (Recall) de Device Recall enpath Myopore Bipolar 54 cm Epicardial Lead Sutureless Myocardial Pacing Lead

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Greatbatch Medical.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    56324
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0287-2011
  • Fecha de inicio del evento
    2010-05-13
  • Fecha de publicación del evento
    2010-11-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93235
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Permanent pacemaker electrode - Product Code DTB
  • Causa
    The myopore bipolar epicardial leads packaging is labeled as unipolar leads. the lead body itself is correctly labeled as bipolar. this could result in a bipolar lead being implanted with a pulse generator operating in unipolar mode.
  • Acción
    Greatbatch Medical issued an Urgent Medical Device Recall letter dated May 13, 2010 to their distributor. The letter described the problem and product involved, and gave the action required which included: 1) immediately discontinue distribution of the units and return any unused units to Greatbatch Medical. 2) Reconcile medical recordsbetween BSC and Greatbatch Medical to confirm implant data 3) Confirm pulse generator type (bipoloar, unipolar, or unknown) used with each serial number listed Greatbatch will work with customers to contact physicians as necessary regarding patient monitoring. Greatbatch Medical can be contacted at 763-951-8312.

Device

Device Recall enpath Myopore Bipolar 54 cm Epicardial Lead Sutureless Myocardial Pacing Lead
  • Modelo / Serial
    serial numbers: 123070, 123072, 123073, 123075 thru 123092, 123094, 123095, 123097 thru 123104, 123431, 123432, 123433.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: to USA and Europe, through distributor in MN.
  • Descripción del producto
    enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in unopened, undamaged package have been sterilized by ethylene oxide gas. Manufactured by enpath medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • Dirección del fabricante
    Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis MN 55441
  • Empresa matriz del fabricante (2017)
    Integer Holdings Corporation
  • Source
    USFDA