Events

Rappel de Device Recall STREAMLINE Bipolar Temporary Myocardial Pacing Lead

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medtronic Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    51292
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1173-2009
  • Date de mise en oeuvre de l'événement
    2009-02-06
  • Date de publication de l'événement
    2009-04-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-05-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79635
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Temporary Pacemaker Electrode - Product Code LDF
  • Cause
    Medtronic is recalling one lot of streamline bipolar myocardial temporary pacing leads, model 6495, lot jgd880205f. this lot of product contains incorrect inner pouch labeling, instead of 6495 it is labeled 6500. the outer carton, shelf box labeling, and instructions for use are correct, and the actual product shipped was consistent with the product ordered. no adverse patient effects have b.
  • Action
    Consignees were sent on 2/6/09 a Medtronic " Urgent Medical Device Recall Notice" dated February 6, 2009. The letter was sent to Risk Mangers. The letter described the product, problem, and requested the removal and quarantine of the affected, unused product. They asked consignees to sign and return the attached recall certificate regarding the status of affected product remaining at their facility. Their Medtronic Sales Representative will contact them to arrange the return of any affected inventory or customers may follow the instructions provided on the attached certificate.

Device

Device Recall STREAMLINE Bipolar Temporary Myocardial Pacing Lead
  • Modèle / numéro de série
    Lot # JDG880205F
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- including states of AK, AZ, CA, CO, CT, ID, IL, IN, KS, MI, MS, NE, NV, NH, NM, NY, NC, OH, OR, PA, TN, TX, VA, WA, and WI.
  • Description du dispositif
    Medtronic STREAMLINE Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF 6495F, Medtronic, INC., Minneapolis, MN 55432
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • Adresse du fabricant
    Medtronic Inc, 710 Medtronic Pkwy, Minneapolis MN 55432-5603
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA